regulatory affairs manager

Qatar Airways

<div><div><div><div><div><div><div><div>Job title
</div><div>Regulatory Affairs Manager
</div></div><div><div>Ref #
</div><div>227229
</div></div><div><div>Location
</div><div>Qatar - Doha
</div></div><div><div>Job family
</div><div>Pilots &amp; Flight Operations
</div></div><div><div><ul><li>Closing date: 17-Oct-2025</li></ul><br>
</div></div></div></div></div><div><div><div><div><div><p><b>About the role:</b></p><p>
Qatar Airways are pleased to announce an incredibly exciting opportunity to join our Flight Operations - Regulatory Affairs team as a Regulatory Affairs Manager to be based in Doha, Qatar.</p><p>
As a Regulatory Affairs Manager, you will work closely with Head of Regulatory Affairs to ensure effective liaison with Qatar Civil Aviation Authority (QCAA) for matters associated with crew member certificates and CAMO related aircraft documentation. You will also support in ensuring regulatory compliance of Qatar Airways by providing guidance and interpretation of the means to comply with the local and international regulations and requirements.</p><p><b>
Specific responsibilities for the role include:</b></p><ul><li><p>
Formulate internal procedures, maintain and implement Regulatory Affairs Business Process Manual to uphold Qatar Airways standards.</p></li><li><p>
Establish a strong relationship with Qatar Civil Aviation Authority (QCAA), relevant Civil Aviation Authority (CAA) and internal stakeholders in order to achieve seamless connection and effective communication facilitating successful completion of tasks/projects.</p></li><li><p>
Maintain current knowledge of Qatar Civil Aviation Regulation (QCAR) Nos. 1001, 1002 and 1003 of 2006; and QCAR No. 068 of 2022, including proposed and final regulations and procedures to ensure that internal stakeholders receive guidance based on an updated regulatory information.</p></li><li><p>
Assess the impact of proposed regulations to Qatar Airways fleet and operations in order to support the affected departments prepare before its implementation date.</p></li><li><p>
Participate in the promulgation of proposed new or amended Civil Aviation regulations by providing position/comments to the Civil Aviation Authority thereby safeguarding Qatar Airways interest.</p></li><li><p>
Prepare all Continuing Airworthiness Management Organization (CAMO) related application packages and submit it through QCAA e-services portal to ensure timeliness and compliance with regulatory requirements.</p></li><li><p>
Manage applicable crew Member Certificate (CMC) applications for Qatar Civil Aviation Authority (QCAA) by overseeing application submission to ensure accuracy and compliance with the Qatar Civil Aviation Regulation (QCAR) requirements/procedures.</p></li><li><p>
Maintain aircraft documentation records using quality management system (QAMS), FlyDocs, etc. to ensure all certifications are available throughout the life cycle of the aircraft.</p></li><li><p>
Provide aircraft documentation (certificate of registration, certificate of airworthiness, export Certificate of airworthiness) to other Qatar Airways departments based on their request thus supporting their business requirements.</p></li></ul><p><b>
Be part of an extraordinary story</b><br>
Your skills. Your imagination. Your ambition. Here, there are no boundaries to your potential and the impact you can make. You&rsquo;ll find infinite opportunities to grow and work on the biggest, most rewarding challenges that will build your skills and experience. You have the chance to be a part of our future, and build the life you want while being part of an international community. Our best is here and still to come. To us, impossible is only a challenge. Join us as we dare to achieve what&rsquo;s never been done before.<br>
Together, everything is possible.</p>
</div></div></div></div></div><div><div><div><h3 class="jobSectionHeader"><b>Qualifications
</b></h3></div></div><div><div><div><div><p><b>About you</b></p><p>
The successful candidate will have the following skills and qualifications:</p><ul><li><p>
Relevant College or University qualifications with minimum 7 years of job-related experience.</p></li><li><p>
Experience in Civil aviation requirements analysis and project management preferred.</p></li><li><p>
Previous Regulatory Affairs experience will be added advantage.</p></li><li><p>
Knowledge of QCAR Nos. 1001, 1002 and 1003 of 2006; and QCAR No. 068 of 2022.</p></li><li><p>
Strong understanding of regulatory applications and aircraft documentation processes.</p></li><li><p>
Familiarity with Quality/Compliance Monitoring and SMS.</p></li><li><p>
Knowledge of Regulatory Affairs and its functions.</p></li><li><p>
Knowledge of QCARs and ICAO &amp; IATA standards.</p></li><li><p>
Conversant with aviation terms and terminology.</p></li><li><p>
Ability to draft concise responses to QCAA queries making references to the relevant regulations.</p></li><li><p>
Analytical skills. Ability to analyze civil aviation requirements applicability.</p></li><li><p>
Ability to manage projects identifying risks and opportunities.</p></li><li><p>
Excellent Communication Skills (Verbal &amp; Written English).</p></li></ul><p><b>
About Qatar Airways Group</b><br>
Our story started with four aircraft. Today, we deliver excellence across 12 different businesses coming together as one. We&rsquo;ve grown fast, broken records and set trends that others follow. We don&rsquo;t slow down by the fear of failure. Instead, we dare to achieve what&rsquo;s never been done before. So whether you&rsquo;re creating a unique experience for our customers or innovating behind the scenes, every person contributes to our proud story. A story of spectacular growth and determination. Now is the time to bring your best ideas and passion to a place where your ambition will know no boundaries, and be part of a truly global community.</p><p><b>
How to apply</b><br>
If you&rsquo;re ready to join a progressive team and have a challenging and rewarding career, then apply now by uploading your CV and completing our quick application form.</p><br>
</div></div><div></div><div><div><br>
<div><b>About Qatar Airways Group
</b></div><br>
Our story started with four aircraft. Today, we deliver excellence across 12 different businesses coming together as one. We&rsquo;ve grown fast, broken records and set trends that others follow. We don&rsquo;t slow down by the fear of failure. Instead, we dare to achieve what&rsquo;s never been done before.<br>
<br>
So whether you&rsquo;re creating a unique experience for our customers or innovating behind the scenes, every person contributes to our proud story. A story of spectacular growth and determination. Now is the time to bring your best ideas and passion to a place where your ambition will know no boundaries, and be part of a truly global community.<br>
</div></div><div><div>https://aa115.taleo.net/careersection/QA_External_CS/jobapply.ftl?lang=en&amp;job=227229</div></div></div></div></div></div></div></div>

Regulatory Affairs Manager

Wonder Products Group of Companies Pvt. Ltd.

<p><b>Job Opportunity at Wonder Products Group of Companies </b></p><p><b>Job Title:</b><i><b>Compliance and Regulatory Affairs Manager &ndash; Domestic &amp; International</b></i><br/><b>Location:</b> Netaji Subhash Place (NSP), New Delhi<br/><b>Experience Required:</b> 5+ Years<br/><b>Preferred Industry:</b> Pharmaceuticals / Cosmetics / Healthcare</p><p><b>About Wonder Products Group</b></p><p>Wonder Products Group of Companies is a trusted leader in <b>contract manufacturing &amp; private-label solutions</b>, specializing in <b>personal care, hair care, skincare, derma cosmetics, pharma, detergents, aerosols, and veterinary products</b>. With a strong presence in both domestic and international markets, we are committed to delivering innovative and compliant solutions to our clients.</p><p><b>Job Summary</b></p><p>We are seeking an experienced <b>Compliance and Regulatory Affairs Manager</b> to ensure that our products meet all applicable <b>domestic and international regulatory requirements</b>. The role involves coordinating regulatory submissions, monitoring changes in regulations, managing product registration and labeling, and supporting compliance programs across multiple regions.</p><p><b>Key Responsibilities</b></p><ul><li>Ensure compliance with regulatory frameworks: <b>FDA (USA), EU Cosmetics Regulation, Health Canada, TGA (Australia), ASEAN, GCC, CDSCO, BIS (India)</b>.</li><li>Maintain updated knowledge of global and domestic regulatory requirements.</li><li>Liaise with regulatory bodies for approvals, certifications, and registrations.</li><li>Prepare, review, and submit <b>dossiers, technical files, and product registrations</b>.</li><li>Draft/review <b>product labeling, safety data sheets, and claims</b> to ensure accuracy.</li><li>Collaborate with R&amp;D, QA, and Production to ensure adherence to <b>GMP, ISO standards, and compliance processes</b>.</li><li>Manage <b>audits, inspections, complaints, adverse event reporting, and recalls</b>.</li><li>Conduct <b>training sessions</b> on regulatory requirements and compliance.</li><li>Track regulatory changes and communicate business impacts.</li><li>Support <b>marketing and supply chain</b> teams in ensuring compliant claims and raw material standards.</li><li>Coordinate with legal teams to mitigate risks.</li></ul><p><b>Key Skills &amp; Qualifications</b></p><ul><li>Bachelor&rsquo;s/Master&rsquo;s in <b>Pharmacy, Chemistry, Life Sciences, or Regulatory Affairs</b>.</li><li><b>5+ years</b> of experience in regulatory affairs &amp; compliance (pharma/cosmetics/healthcare preferred).</li><li>Strong understanding of <b>global &amp; domestic frameworks</b> and product registration processes.</li><li>Familiarity with <b>GMP, ISO, safety standards, and quality systems</b>.</li><li>Excellent <b>documentation, presentation, and stakeholder management</b> skills.</li><li>Experience preparing <b>dossiers, labeling, and audit reports</b>.</li><li>Knowledge of regulatory software systems is an advantage.</li></ul><p><b>Preferred Experience</b></p><ul><li>Hands-on experience with <b>FDA, EU, Health Canada, CDSCO</b>, or similar authorities.</li><li>Understanding of <b>safety testing, stability studies, and certification processes</b>.</li><li>Exposure to <b>cross-border compliance and product registration</b>.</li><li>Ability to thrive in fast-paced, multi-stakeholder environments.</li></ul><p><b>Reporting Structure</b></p><ul><li><b>Reports to:</b> Head &ndash; Quality Assurance / Regulatory Affairs Director</li><li><b>Interacts with:</b> R&amp;D, Marketing, Legal, Supply Chain, Production, External Regulatory Bodies</li></ul><p><b>Key Performance Indicators (KPIs)</b></p><ul><li>Timely submission of filings &amp; approvals</li><li>100% compliance with global and local regulations</li><li>Accuracy in labeling &amp; product claims</li><li>Audit/inspection success with minimal observations</li><li>Training effectiveness &amp; cross-functional awareness</li><li>Reduction in compliance-related delays/recalls</li></ul><p><b>Regional Office:</b> #1404-1405, 14th Floor, Gopal Heights, Netaji Subhash Place, New Delhi - 110034</p><p>Job Types: Full-time, Permanent</p><p>Pay: &#8377;480,000.00 - &#8377;720,000.00 per year</p><p>Ability to commute/relocate:</p><ul><li>Pitampura, Delhi, Delhi: Reliably commute or planning to relocate before starting work (Required)</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Work Location: In person</p>

Compliance & Regulatory Affairs Manager

Danone

<div>About the job
<p><b>
Danone T&uuml;rkiye</b> is looking for a talented colleague for the <b>&quot;Regulatory Affairs Manager </b>&quot; position. Take this opportunity to GROW together!</p><br>
<p></p>
<p>
As a Regulatory Affairs Manager, you will be an <i>individual contributor</i> in this role and reporting to the <i>Head of Regulatory Affairs.</i></p><br>
<p></p>
<p><b><i>
In this role you will;</i></b><i>
 </i></p><p><i>Ensure sufficient compliance governance to meet regulatory obligations of the dairy business unit
</i></p><ul><li><i>Ensure full compliance of recipes, products, labeling and any kind of product communication (press, TV, online, etc.)
</i></li></ul><ul><li><i>Provide regulatory assessments for innovation projects to give direction by exploiting opportunities where possible and avoiding regulatory hurdles
</i></li></ul><ul><li><i>Lead and manage product approval and licensing process related to products
</i></li></ul><ul><li><i>Propose &amp; implement action plans in response to regulatory changes in the market</i></li></ul>
<ul><li><i>Anticipate the development of new regulations and effectively communicate company position in relevant external environment
</i></li></ul><ul><li><i>Advocacy and lobby on new regulation development via trade associations and by establishing effective relationship with authorities
</i></li></ul><p><i>&bull; Educate all relevant functions on regulatory compliance to ensure consistent implementation of regulatory requirements &bull; Identify and predict issues that could impact the business and communicate them to relevant business partners; assist them to implement agreed actions
</i></p>About you
<ul><li>Have at least 5 years of related experience in Food, Beverage sector in Regulatory Affairs department</li></ul>
<ul><li>University degree in Food Engineer, Chemical Engineer, or relevant disciplines</li></ul>
<ul><li>Have in knowledge of food and beverages&rsquo; regulations and related EU regulations (preferably)</li></ul>
<p>
&bull; Excellent command of written and spoken English &bull; Attention to details, very-well organized, and logical/systematic thinking</p>
<ul><li>Capable to pro-actively engage and liaise with internal/external stakeholders (good communication skills)</li></ul>
About us
<p><b>
Being a Danoner means that you create your own working experience.</b></p><br>
<ul>
<li>You could design your own way of working with our hybrid working model.</li>
<li>Our head office is in Ata&#351;ehir.</li>
<li>You could decide your daily 8-hours of working period within our flexible-working hours practice.</li>
<li>We know that you will have home expenses during home office days. So, Danone supports you for your expenses with an allowance as well!</li>
<li>Summers are flexible here! You could work fully remote for 4 weeks during July and August.</li>
<li>We also enjoy Fridays during summer period between July and August by finishing our works by 1500 and enjoy the rest of the day and starting the weekend earlier.</li>
Danone offers various types of leave days to support Danoners&rsquo; work-life balance and well-being. We have a wide variety of leave types, such as in your first year 5 days of &quot;Im New in Danone Leave&quot;; 1 day of &quot;My Future is Good Leave&quot; for our social responsibility activities. These options cater to different aspects of employees' lives and needs, reflecting the company's commitment to not only professional growth but also personal and social responsibilities.<br>
<li>
<br>
<br>
</li></ul><p>We are proud to promote diversity and equal opportunity within our teams. We believe that our differences will make a difference, and that an inclusive work environment will drive our growth as a company, as a team, and as individuals. We will therefore consider all implementations* by fostering an inclusive work culture where everyone can feel at home.<br>
<br>
All nominations will be considered regardless of origin, background, religion, sex, sexual orientation, age, gender identity, disability.<br>
<br>
<b>Working with us</b> is about being able to do things your way. The way you work, the way you develop, the way you progress,<b> i</b><b>t&rsquo;s all up to you.</b><br>
<br>
Working here, you&rsquo;ll need to enjoy a fast-paced environment, a little complexity and challenging tasks but it is packed with opportunities. You will work for some of the best-known brands in the world, such as Activia, Danone, Danino, Danette, Aptamil, Bebelac, Hayat, and S&#305;rma, and we absolutely guarantee that you can just be yourself.<br>
<br>
<b>Be innovative and entrepreneurial and the impact you could make might just amaze you</b>. Join our movement for a healthier world. <b>One Planet One Health BY YOU.</b><br>
<br>
At Danone T&uuml;rkiye, inspired by our <b>B Corp</b> journey, we continuously challenge ourselves to improve and measure our social and environmental impact. This journey inspires us to constantly challenge ourselves, measure what truly matters, and create long-term value &mdash; not just for our business, but for our people, partners, communities, and future generations. <b>If you&rsquo;re looking to grow your career with purpose, you&rsquo;re in the right place.</b></p><br>
<p></p>
<p><b>
What&rsquo;s next?</b><br>
<br>
Visit our website www.danone.com to discover more about us and to find out how you could be part of it all!</p></div>

Regulatory Affairs Manager (Temporary)

SOLARIAN ASTRA PVT LTD

<div>
 <p>
  <strong>
   Job Title: Senior Manager &ndash; Regulatory Affairs
  </strong>
 </p>
 <p>
  <strong>
   Company: Solarian Astra Pvt. Ltd.
  </strong>
 </p>
 <p>
  <strong>
   Location: Noida, India | Hybrid
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   About Solarian Astra
  </strong>
 </p>
 <p>
  Solarian Astra Pvt. Ltd. is a leading one-stop solution for solar projects, covering the entire lifecycle from planning and land acquisition to EPC, commissioning, regulatory approvals, charging, and maintenance. We deliver integrated, end-to-end solutions for solar projects across India, combining technical excellence with a commitment to sustainable, reliable energy. We foster a diverse, inclusive, and high-performance work culture focused on innovation and impact.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Role Overview
  </strong>
 </p>
 <p>
  The Senior Manager &ndash; Regulatory Affairs will monitor and analyze regulatory and policy developments in the renewable energy sector, prepare internal advisories, and support policy advocacy initiatives. This role includes engaging in external meetings, conducting in-depth research, documentation, and compliance tracking to ensure project readiness and timely submissions.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <strong>
   1. Regulatory Tracking &amp; Analysis
  </strong>
 </p>
 <ul>
  <li>
   Monitor notifications, orders, and regulations from CERC, SERCs, MNRE, MoP, CTUIL, CSTUs/CTUs, state energy commissions, and other authorities; synthesize implications for the business.
  </li>
  <li>
   Develop detailed PowerPoint presentations on new policies, rules, and regulations for internal use and leadership reviews.
  </li>
  <li>
   Prepare clear, concise summaries and impact notes for cross-functional teams.
  </li>
 </ul>
 <p>
  <strong>
   2. Documentation &amp; Drafting
  </strong>
 </p>
 <ul>
  <li>
   Draft consultation responses, regulatory submissions, and briefing materials for review by the Head of Regulatory Affairs.
  </li>
  <li>
   Maintain a centralized repository of policy documents, past submissions, and regulatory correspondence.
  </li>
  <li>
   Prepare formats and letters required for permits, approvals, and authorizations.
  </li>
  <li>
   Develop and maintain energy cost sheets and models (e.g., Captive, Group Captive, Third-Party PPA structures) for financial planning and feasibility analyses.
  </li>
 </ul>
 <p>
  <strong>
   3. Compliance Support
  </strong>
 </p>
 <ul>
  <li>
   Maintain trackers for statutory filings, licenses, and regulatory obligations across projects.
  </li>
  <li>
   Alert relevant teams to upcoming deadlines and regulatory changes.
  </li>
  <li>
   Manage statutory clearances, liaising with appropriate authorities and internal stakeholders.
  </li>
  <li>
   Coordinate permissions and approvals (e.g., RLDC, PTCC, CEIG, Section-64, Section-168, transmission/line crossing, grid connectivity, National/State Highway crossing, NOCs from civil aviation, forest, pollution control boards, and other sectoral centre or state regulators) as applicable to projects.
  </li>
 </ul>
 <p>
  <strong>
   4. Internal Coordination
  </strong>
 </p>
 <ul>
  <li>
   Liaise with Legal, Project, Finance, and Business teams to collect inputs for regulatory submissions.
  </li>
  <li>
   Provide regulatory references to support project development, bidding, and commercialization strategies.
  </li>
  <li>
   Facilitate cross-functional review of regulatory documents to ensure accuracy and alignment with business objectives.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <p>
  <strong>
   Educational Requirements
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Engineering, Economics, Law, Public Policy; MBA in Power Management/Energy Management preferred.
  </li>
  <li>
   Advanced degree or professional certifications in related fields (e.g., Regulated Industries, Policy Analysis) are a plus.
  </li>
 </ul>
 <p>
  <strong>
   Experience
  </strong>
 </p>
 <ul>
  <li>
   3&ndash;5+ years in regulatory affairs, policy analysis, or compliance within the renewable energy/power sector (solar, wind, BESS or hybrids).
  </li>
 </ul>
 <p>
  <strong>
   Technical Expertise
  </strong>
 </p>
 <ul>
  <li>
   Strong research, drafting, and analytical capabilities.
  </li>
  <li>
   Proficiency in MS Office (Word, Excel, PowerPoint); experience with data analysis tools is a plus.
  </li>
 </ul>
 <p>
  <strong>
   Preferred Attributes
  </strong>
 </p>
 <ul>
  <li>
   Solid understanding of electricity laws, renewable energy policies, open access, and transmission regulations.
  </li>
  <li>
   Excellent written and verbal communication skills; ability to interact with clients, internal teams, and authorities.
  </li>
  <li>
   Prior experience in renewable energy project development and regulatory submissions.
  </li>
  <li>
   Strong stakeholder management and relationship-building skills.
  </li>
  <li>
   Leadership capability and team coordination experience.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Additional Information
  </strong>
 </p>
 <p>
  <strong>
   We Offer
  </strong>
 </p>
 <ul>
  <li>
   An international, collaborative work environment with diverse colleagues.
  </li>
  <li>
   Open, inclusive culture supporting professional and personal growth.
  </li>
  <li>
   Challenging and impactful assignments across projects.
  </li>
  <li>
   Competitive remuneration aligned with experience.
  </li>
  <li>
   Opportunities for career advancement within a growing organization.
  </li>
 </ul>
 <p>
  <strong>
   Equal Opportunity &amp; Accessibility
  </strong>
 </p>
 <ul>
  <li>
   Solarian Astra Pvt. Ltd. is an equal opportunity employer. We value diversity and are committed to an accessible recruitment process and accommodations as needed to support applicants with disabilities.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   How to Apply
  </strong>
 </p>
 <p>
  Please send your resume and a cover letter outlining your regulatory experience and fit for this role to [admin@solarianastra.com] with the subject line &ldquo;Manager &ndash; Regulatory Affairs Application.&rdquo;
 </p>
</div>


Senior Manager Regulatory Affairs

Human Capital HR Solutions

<p>The <b>Assistant Manager &ndash; Regulatory &amp; Corporate Affairs</b> will ensure full compliance with all statutory and regulatory requirements while supporting the company&rsquo;s legal, licensing, and corporate governance activities. The role requires close coordination with internal departments, legal counsel, and government authorities to maintain a compliant and well-governed business environment.</p><p><b>Key Responsibilities:</b></p><ul><li>Ensure compliance with <b>local laws, regulatory bodies, and industry standards.</b></li><li>Manage <b>regulatory filings, licenses, renewals, and statutory documentation.</b></li><li>Liaise with <b>government departments, legal advisors, and industry associations.</b></li><li>Support <b>corporate documentation</b>, board meetings, and policy development.</li><li>Prepare and review <b>contracts, agreements, and legal correspondences.</b></li><li>Facilitate <b>internal and external audits</b> conducted by regulatory authorities.</li><li>Monitor and report on <b>new or updated regulations</b> affecting company operations.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs120,000.00 - Rs170,000.00 per month</p><p>Work Location: In person</p>

Assistant Manager – Regulatory & Corporate Affairs

Werfen

<div><div><div><h3 class="jobSectionHeader"><b>Job Information</b></h3><div>
Number</div>
<div>ICIMS-2025-8307</div>
<div>Job function</div>
<div>QA&amp;RA</div>
<div>Job type</div>
<div>Full-time</div>
<div>Location</div>
<div>San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States
</div><div>Country</div>
<div>United States</div>
<div>Shift</div>
<div>1st</div>
<h3 class="jobSectionHeader"><b>About the Position</b></h3><div><div><h4 class="jobSectionHeader"><b>
Introduction</b></h4>
<div><p><b>Werfen</b></p><p><br>
</p><p>Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.</p><p></p><p><br>
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We&rsquo;re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.</p></div>
</div></div><div><div><h4 class="jobSectionHeader"><b>Overview</b></h4>
<div><p><b>Job Summary</b></p><p>
Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers. Activities are performed in accordance with standard operating procedures (SOPs), Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies. As a member of the Werfen management team is responsible for role modeling Werfen Values and Role of the Manager competencies and expectations.</p><p>
Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership. Responsible for managing a team of technical staff to develop regulatory plans for products, to prepare regulatory submissions such as 510(k), EU IVDR Technical Documentation, etc, to manage communications with Regulatory Agencies e.g. FDA, EU Notified Bodies, Health Canada, etc., For on-market products, the Regulatory Affairs Manager will oversee and assist in conducting regulatory market authorization impact assessments for product changes and associated regulatory submissions in the regions where products are marketed. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion. The Regulatory Affairs Manager will champion continuous improvement efforts and lead department initiatives. This role will also be responsible for managing the regulatory intelligence program in collaboration with internal and external stakeholders and supporting initiatives for global regulatory compliance for Werfen invitro diagnostic (IVD) products.
</p></div></div></div><div><div><h4 class="jobSectionHeader"><b>Responsibilities</b></h4>
<div><p><b>Key Accountabilities</b></p><ul><li>
Teamwork: Coordinate with department leadership and other cross-functional areas including R&amp;D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, product changes, international product registrations, review of Advertising &amp; Promotional Materials, etc. Model effective team collaboration behavior.</li><li>
New Product Development Support: In collaboration with Department Leadership, assist the Regulatory Affairs team in developing regulatory plans and oversee implementation for introducing new products in various geographies, including but not limited to the United States, European Union, Canada, Australia, Japan, China, etc. Partner with regional partners globally as needed to ensure product development plans are comprehensive in addressing global regulatory requirements and supporting global regulatory approvals. Oversee and assist the Regulatory Affairs team in preparing and submitting regulatory submissions, including 510(k)s, Pre-submissions, IVDR Technical Documentation, etc. for new product development projects. Oversee and manage communications with Regulatory Agencies during product development and during the review of regulatory submissions. Ensure product development plans, analytical and clinical studies are aligned with Regulatory Agency expectations necessary for obtaining regulatory market approvals. Partner with Regulatory Affairs staff and cross-functional management to manage expectations and ensure overall smooth execution of regulatory strategies and plans in new product development projects. Ensure timely preparation of regulatory submissions through effective coordination of activities across Regulatory Affairs staff and cross-functional teams. Ensure regulatory submissions and associated communications with Regulatory Agencies are appropriately maintained in the internal document repositories.</li><li>
On-Market Support (Sustaining): Provide leadership, guidance and assistance to the Regulatory Affairs team in the regulatory impact assessments of changes on existing Market Authorizations that include but are not limited to design changes, changes to product composition, manufacturing processes, and the labeling of products. Oversee and assist in completion of regulatory submissions necessary for product changes. Review and approve product labeling, scientific papers, customer and public communications, advertising, and promotional materials to ensure compliance with regulatory requirements concerning advertising and promotion.</li><li>
Regulatory Intelligence: In collaboration with Department Leadership, oversee and perform ongoing surveillance of new and revised regulatory requirements globally. Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies. Participation in trade and professional organizations is strongly recommended. Monitor and analyze the development of new and emerging regulations, guidances, and recognized standards in marketed geographies. Coordinate plans for complying with new and emerging regulations, guidances, and standards to affected functions. Communicate new regulatory requirements and regulations and their impact on the business or portfolio to senior management.</li><li>
Department Management: Establish and monitor priorities and goals for the Regulatory Affairs team concerning new product development support and sustaining of on-market products. Educate and broaden the regulatory knowledge of the department, other functions. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Regulatory processes. Perform Regulatory related periodic document review and update documents as necessary. Support regulatory inspections and third-party audits. Provide back-up support for Regulatory Team.</li><li>
Team Management: Responsible for overall performance of department operations, personnel and budget. Leads department to achieve department and company goals. Responsible for hiring, development and performance of team. Ensure a culture of accountability, teamwork, collaboration, continuous improvement and compliance to company policies and procedures, legal requirements and the Quality Systems. Ensure effective performance management and development activities are completed, including onboarding, training, setting expectations, and providing meaningful feedback. Maintain regular and transparent communications through effective use of one-on-one meetings, team meetings and other forms of formal and informal communications. Proactively manage employee relations issues; use judgement in consulting with department leadership and Human Resources. May include managing people managers to ensure business acumen, commitment to Werfen Values, as well as Role of the Manager comptencies &amp; expectations.</li></ul><p></p><p><b><br>
Networking/Key Relationships</b></p><ul><li>
R&amp;D Teams
</li><li>Project Management</li><li>
Marketing
</li><li>Quality Engineering</li><li>
Manufacturing
</li><li>Global Werfen RA/QA Personnel and Regional Partners
</li><li>Product Testing
</li><li>Post-market compliance
</li></ul></div></div></div><div><div><h4 class="jobSectionHeader"><b>Qualifications</b></h4>
<div><p><b>Minimum Knowledge &amp; Experience</b></p><p></p><p><br>
Education:</p><ul><li>
Bachelor&rsquo;s degree in bioengineering/biomedical engineering,biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.
</li><li>Regulatory Affairs Certification preferred</li></ul><p>
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.</p><p></p><p><br>
Experience:</p><ul><li>
Minimum 8 years of experience in Regulatory Affairs, of which a minimum of 5 years must be in IVD Regulatory Affairs.
</li><li>Minimum 5 years of experience in managing regulatory professionals including responsibility for staffing management, professional development, budget management and adherence with procedures, policies and regulations.
</li><li>Demonstrated success in obtaining regulatory approvals in the major geographies including but not limited to the US, EU (under IVDR) and other major geographies.
</li><li>Hands-on experience in preparing regulatory submissions including 510(k) and IVDR Technical Documentation and managing relationships and communications with Regulatory Agencies such as FDA, EU Notified Body, etc.
</li><li>Experience managing relationships with a variety of stakeholders and cross-functional teams.
</li><li>Experience with scientific writing and communications</li></ul><p><b>
Skills &amp; Capabilities</b></p><ul><li>
Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU (under IVDR), Canada, and Australia.
</li><li>Working knowledge of regulatory requirements for obtaining global Regulatory Approvals in Asia Pacific, Latin America and Middle East.
</li><li>Strong knowledge of IVD product development process.
</li><li>Strong knowledge of requirements, methods and data analysis utilized in the analytical and clinical validation of IVD products. Understanding of CLSI guidelines preferred.</li><li>
Strong ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
</li><li>Strong skills in verbal and written communication including scientific writing and presentation.</li><li>
Strong ability to mentor, train, and develop skills of staff in regulatory knowledge and related processes. Ability to manage and coordinate the activities of direct reports.
</li><li>Strong skills in leadership, influence, and negotiation.</li><li>
Ability to lead cross-functional projects with a focus on collaboration and teamwork to a timely and effective conclusion.</li><li>
Ability to function effectively with ambiguity in a rapidly changing environment.</li><li>
Ability to develop proactive and creative approaches to problem solving.</li><li>
Advanced ability to organize and complete multiple tasks in a fast-paced environment.
</li><li>Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.</li><li>
Advanced knowledge of electronic publishing/file management system</li></ul><p></p><p><b><br>
Location / Office
</b></p><ul><li>Must reside in the San Diego area</li><li>
Must be present in the office Mon &ndash; Friday</li></ul><p><b>
Supervisory Experience</b></p><ul><li>
Prior experience managing direct reports is required</li></ul><p></p><p><b><br>
Work Environment:</b></p><p></p><p><br>
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate.</p><p></p><p><b><br>
Other Duties and Acknowledgement:</b></p><p>
The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.</p><p></p><p><br>
The salary range for this position is currently $130,000- $190,000 annual. Individual compensation is based on the candidate&rsquo;s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.</p><p></p><p><br>
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.</p><p></p><p><br>
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual&rsquo;s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.</p><p></p><p><br>
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.</p><p></p><p><br>
www.werfen.com</p></div><br>
</div></div><p></p><div><div><div><p>If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.</p><p></p><p><br>
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual&rsquo;s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.</p><p></p><p><br>
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.</p><p></p><p><br>
www.werfen.com</p></div></div></div></div></div></div><p></p>

Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device IVD Experience

Netflix

<div><p>Netflix is one of the world's leading entertainment services, with over 300 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time.
</p><p></p><p>This is a unique opportunity to make a real impact at the intersection of entertainment, policy, and global affairs. As Senior Manager, Global Affairs (India), you will play a pivotal role in shaping Netflix&rsquo;s policy agenda in one of the world&rsquo;s most dynamic markets. We&rsquo;re looking for someone who thrives on joining new dots&mdash;proactively spotting emerging issues, building thought leadership with think tanks and experts, and helping align our work with long-term goals. You&rsquo;ll be central to developing our Indian regulatory strategy, forging trusted relationships with policymakers and stakeholders, and advising the business on both established and fast-evolving topics such as artificial intelligence, gaming, and state-level policy. If you are a proactive public affairs professional with a strong network, a deep understanding of the Indian policy landscape, and a knack for connecting issues, stakeholders, and teams, this is your chance to drive meaningful change and help shape the future of digital entertainment in India.
</p><p></p><p><b>Key Responsibilities:
</b></p><ul><li><p>Proactively identify and analyze emerging policy trends, reports, and regulatory developments&mdash;across national and state levels&mdash;including those surfaced in government documents, think tank publications, and media coverage.
</p></li><li><p>Build and maintain strong, strategic relationships with government officials, policymakers, think tanks, industry associations, and other key stakeholders to advance Netflix&rsquo;s policy agenda.
</p></li><li><p>Develop and execute thought leadership initiatives that help shape public discourse and inform government thinking on topics such as artificial intelligence, gaming, and digital regulation.
</p></li><li><p>Advise internal teams on the evolving policy landscape, connecting the dots between new issues, stakeholders, and business objectives to inform strategy and decision-making.
</p></li><li><p>Collaborate cross-functionally with legal, content, and product teams to ensure policy strategies are aligned with Netflix&rsquo;s long-term goals and business priorities.
</p></li><li><p>Represent Netflix at meetings, conferences, and forums, and support local and state-level initiatives through advocacy and coalition-building.
</p></li><li><p>Prepare clear, persuasive briefing materials, presentations, and advocacy documents for both internal and external audiences, synthesizing insights from diverse sources to drive impactful engagement.
</p></li></ul><p></p><p><b>Qualifications
</b></p><ul><li><p>Masters&rsquo;s degree or equivalent practical experience; advanced or legal degree is a strong asset.
</p></li><li><p>12+ years of hands-on experience in policy analysis, advocacy, or campaigns related to technology, media, or digital policy, with a proven track record in government, think tanks, public interest groups, industry associations, or corporate public policy teams.
</p></li><li><p>Demonstrated ability to independently drive projects and deliver results&mdash;comfortable being hands-on and not just delegating.
</p></li><li><p>Strong background in public policy issues affecting the technology and media sectors, serving as a trusted advisor to business, product, legal, and compliance teams.
</p></li><li><p>Extensive experience engaging with government, regulatory agencies, and external stakeholders, including presenting and shaping views in public forums, meetings, and conferences.
</p></li><li><p>Familiarity with the policymaking process, including parliamentary procedure, committee work, and the development of reports and policy documents.
</p></li><li><p>Exceptional analytical, written, and verbal communication skills, with the ability to clearly articulate complex issues and influence diverse audiences.
</p></li><li><p>Proven ability to build and maintain strong relationships across all levels of government and with external partners.
</p></li><li><p>Experience working in small, cross-functional teams and managing multiple priorities in a dynamic, fast-paced environment.
</p></li><li><p>Proficiency in English and Hindi required; knowledge of additional Indian languages is a plus.
</p></li></ul><p></p><p>Inclusion is a Netflix value and we strive to host a meaningful interview experience for all candidates. If you want an accommodation/adjustment for a disability or any other reason during the hiring process, please send a request to your recruiting partner.
</p><p></p><p>We are an equal-opportunity employer and celebrate diversity, recognizing that diversity builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.</p></div>

Senior Manager, Global Affairs - India

Search 10000+ Regulatory affairs manager jobs near you this October. New roles added regularly across leading industries. Apply today.