regulatory affairs manager

Sandoz

<div>Major accountabilities:
<ul><li>Manages multiple, large and complex local and global regulatory submission projects.
</li><li>Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain local and global products.
</li><li>Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
</li><li>A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
 </li><li>This job is the fully qualified, career-oriented, journey-level position .
</li><li>Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
</li><li>Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
</li><li>Networks with senior internal and external personnel in own area of expertise.
</li>Contributes to many cost center goals and objectives; may contribute to service line goals -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable) 
<li>
 
</li></ul>What you&rsquo;ll bring to the role:
<ul><li>Bachelor&rsquo;s degree in Pharmacy or related field
</li><li>5+ years of relevant regulatory experience with 2+ years in managerial role within pharmaceutical industry
</li><li>Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
</li><li>Experience in interacting with government authorities
</li><li>Strong knowledge of labeling requirements and GxP documentations
</li><li>Attention to detail, organizational skills, and ability to work with documentation
</li>Fluent in English 
<li>
 </li></ul>Work Experience:
<ul><li>Cross Cultural Experience.
</li><li>Managing Crises.
</li><li>Functional Breadth.
</li><li>Project Management.
</li><li>Collaborating across boundaries.
</li>Operations Management and Execution. 
<li>
 
</li></ul>Skills :
<ul><li>Data Analysis.
</li><li>Documentation Management.
</li><li>Lifesciences.
</li><li>Project Management.
</li><li>Regulatory Compliance.
 
</li></ul><h3 class="jobSectionHeader">Why Sandoz?
</h3>Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
Commitment to Diversity &amp; Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.</div>

Regulatory Affairs Manager

Benjamin Moore

<div>Overview:
<div>
Company Overview</div><div>
At Benjamin Moore, our success is attributable to the employees who dedicate their time and talents to the brand and exemplify our core values of openness, integrity, community, excellence, and safety. Benjamin Moore employees enjoy a competitive and well-rounded benefits package, career development options, business resource groups, and opportunities to come together and connect with colleagues. We facilitate growth, development, and purpose for all through an inclusive and engaging workplace.</div><div>
Join us and be part of a brand that inspires creativity, innovation, and passion while supporting locally owned stores in 65 countries.</div><div>
Click here to see how you can paint your future!</div><div></div><div> 
Position Summary</div><div>
The Regulatory Affairs Manager reports to the Director of Regulatory Affairs &amp; Sustainability. Manages the Regulatory Affairs Team working on a complex and diverse set of notification/regulatory requirements across multiple global markets to ensure products are compliant with the relevant regulations before being released to the market. The Regulatory Affairs Manager is responsible for managing all aspects of complex regulatory affairs projects, from product development to the strategic delivery of a global pipeline to multiple markets.</div>
Responsibilities:
<div>
Key Responsibilities</div><ul><li>
Lead and manage registration/notification projects in accordance with the global regulatory frameworks</li><li>
Be the regulatory point of contact in Benjamin Moore for paint and resin global business.</li><li>
Assess any regulatory changes impacting the paint and resin to ensure that future developments and existing products compliance</li><li>
Participate in designated and applicable working groups/committees representing BM to shape regulatory-driven topics in-line with BM&rsquo;s strategic vision, and ensure timely communication to relevant functions</li><li>
Working with the Director to help shape future policy, gather, disseminate &amp; assess regulatory, competitive intelligence for paint and resin</li><li>
Build and conduct training and communication materials to key stakeholders</li><li>
Manage global new product evaluations for raw materials, paint and resin products, with focus on Europe (EU/UK)</li><li>
Supervise complaint Labels and SDS&rsquo;s creation</li><li>
Respond to regulatory questions from international customers.</li></ul>
Qualifications:
<ul><li>BS/MS in chemistry, biology, or related fields, such as biotechnology, toxicology, or the law.</li><li>
5-10 years of experience in a regulatory-related field. Understanding and expertise in conducting regulatory risk assessments.</li><li>
Expertise in European (EU/UK) legislation
</li><li>Ability to lead, motivate, and participate in diverse, multi-functional teams and networks.</li><li>
Effective organization skills and ability to manage a team and complete multiple tasks to meet deadlines.</li><li>
Effective communicator with networking skills and the ability to develop and maintain interpersonal relationships through all levels of an organization.</li><li>
Demonstrated ability to interpret regulations, including REACH, BPR, CLP in EU and UK</li><li>
Previous experience with WERCS regulatory software is desirable.</li></ul> 
Compensation Philosophy
At Benjamin Moore, our brand represents excellence, and we strive to provide a comprehensive total rewards package to match. In addition to a competitive base salary, every exempt and non-exempt role in our organization is eligible for a performance-based annual raise and bonus in recognition of their efforts that contribute to the success of our organization. We conduct regular pay audits using external market data and internal comparisons to ensure our employees are compensated fairly and equitably. 
The salary range listed herein refers to the amount the Company is willing to pay at the time of posting. The actual salary offer will be carefully considered based on a wide range of factors, including your skills, qualifications, experience, job location, and other relevant factors. 
In addition to our monetary compensation package, Benjamin Moore provides a full range of benefits that are personalized to support you physically, financially, and emotionally, through both the big milestones and in your everyday life. 
Benefits include, but are not limited to, the following:<ul><li>Medical/Dental/Vision</li><li>401 (k) match</li><li>PTO starting at 3 weeks' vacation + (7) paid holidays and (5) personal days</li><li>Employer-paid life insurance</li><li>Tuition reimbursement</li></ul> 
You can view the complete benefits package by clicking the following link: 
https://www.benjaminmoore.com/en-us/benjamin-moore-careers?targetid=row-benefits-summary<div></div> 
Engagement, Inclusion + Social Impact
At Benjamin Moore, we don't just accept difference &mdash; we celebrate it, support it, and thrive because it benefits our employees, customers, and community. We remain steadfast in our commitment to cultivating an environment where all are provided the tools and opportunities to thrive in the workplace. Our efforts allow each of us to authentically live our corporate values of Openness, Integrity, Community, Excellence, and Safety.
Our Social Impact initiatives, including strategic partnerships, in-kind donations, and volunteerism, further amplify our ability to positively impact the lives of our stakeholders. We believe that fostering a culture of inclusion and belonging is the right thing to do and essential for our continued success. 
Student Loan Repayment Assistance Program
Benjamin Moore provides Student Loan Repayment Assistance Program to support eligible active employees who graduated from an accredited post-secondary educational institution. The Repayment Program is intended to contribute to reducing employee's student loans. The Company follows all rules and regulations concerning the taxability of student loan repayments provided under applicable law. 
EOE
Benjamin Moore is an equal-opportunity employer that is committed to a culture of inclusion and belonging. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Our commitment to these principles means all employment decisions are made based on qualifications, merit, and business needs. 
#LI-PN1
Pay Range : USD $127,300.00 - USD $150,000.00 /Yr.</div>

Regulatory Affairs Manager (EU/UK)

Akbari Chemicals Industries

Job Opportunity &ndash; Manager Regulatory Affairs &amp; Legal Location: Head Office &ndash; Lahore Company: Akbari Chemical Industries (Pvt.) Ltd.Akbari Chemical Industries (Pvt.) Ltd. is seeking a highly competent and disciplined Manager Regulatory Affairs &amp; Legal. The ideal candidate must be a retired officer from the Armed Forces with strong knowledge of regulatory compliance and legal affairs, particularly in the chemical and fertilizer industry.Key Responsibilities:<ul><li>Handle all matters related to renewal of product licenses from ANF and other government regulatory departments.</li><li>Liaison with government authorities regarding environmental compliance and related issues.</li><li>Manage legal correspondence, regulatory obligations, and compliance matters.</li><li>Ensure strict adherence to industry standards, government regulations, and company policies.</li><li>Provide legal guidance to management and support in contract vetting, agreements, and dispute resolution.</li></ul>Requirements:<ul><li>Must be a retired officer from the Pakistan Armed Forces ( Lt. Colonel or Brig rank equivalent preferred).</li><li>Bachelor&rsquo;s or Master&rsquo;s degree in Law / Business Administration or related discipline.</li><li>Strong exposure to regulatory compliance, legal affairs, and liaison with government departments.</li><li>Excellent communication, leadership, and negotiation skills.</li><li>Ability to work independently and represent the company at high-level government platforms.</li></ul>Job Type: Full-timeApplication Question(s):<ul><li>Are you a military retired person?</li><li>How much experience do you have in regulatory compliance, legal affairs, and liaison with government departments?</li></ul>Work Location: In person

Manager Regulatory Affairs & Legal

<div>Key Accountabilities
<ul><li>Support and manage interface with relevant stakeholders as appropriate to engage, track, obtain and streamline business input/ objectives in key operational areas with regulatory requirements under the telecoms regulatory framework and/or the Telecommunications Digital Government and Regulatory Authority (TDRA) as may be required (e.g. in relation to specific TDRA requests for information, broader regulatory obligations, special projects and/or any other matter falling within the scope of the above framework).
</li><li>Act as primary interface with the TDRA&rsquo;s Technical Affairs personnel and eitc&rsquo;s Technology and Commercial teams in relation to daily management of eitc&rsquo;s requirements for scarce resources and eitc&rsquo;s compliance to:
<ul><li>Internet access policy
</li><li>Mobile number portability
</li><li>Fixed number portability
</li><li>Numbering management
</li><li>National crisis management projects
</li><li>Billing and CPR audits
</li></ul></li><li>in addition to TDRA&rsquo;s requests for actions and &amp; adhoc reports within TDRA&rsquo;s timelines.
</li><li>Manage monitoring of international regulatory developments and international best practice, including supporting submissions/ policy positions with benchmarked data and in relation to recurring team updates as appropriate.
</li><li>Assist in the development of comprehensive planning and processes to ensure that responses to regulatory technology obligations are met.
</li><li>Support development and implementation appropriate overall performance measures in respect of eitc&rsquo;s obligations in respect regulatory compliance.
</li><li>Liaise with Technology, Finance and Commercial and other divisions as required to fulfill the duties of the position;
</li><li>Prepare and support the preparation of submissions, correspondence and other documentation relevant to the policies associated with these matters, and the operation of the policies in the fulfillment of the duties of the position;
</li><li>Represent Regulatory Affairs in meetings with the TDRA, Etisalat and other licensed operators, and in appropriate Industry fora, with a view to influencing regulatory outcomes to the benefit of eitc.
</li></ul>Qualifications:
<ul><li>Bachelor&rsquo;s degree
</li></ul>Experience:
<ul><li>7-12 years of relevant industry experience
</li></ul>Skills:
<ul><li>Excellent spoken and written communication skills in English and Arabic.
</li><li>Understanding of telecommunications and technologies.
</li><li>Ability to work independently or as part of a team.
</li><li>Result and outcome-oriented with attention to detail and quality within required timelines.
</li><li>Flexibility and ability to travel at short notice to meetings, including in Dubai and Abu Dhabi.</li></ul></div>

Manager Regulatory Affairs

Efroze Chemical Industries Pvt Ltd

We Are Hiring! | Assistant Manager / Deputy Manager &ndash; Regulatory Affairs Efroze Chemical Industries (Pvt.) Ltd.Location: Korangi Industrial Area, KarachiQualification: Doctor of Pharmacy (Pharm-D)Experience: 4&ndash;6 years in PharmaceuticalKey Responsibilities:Preparation and submission of regulatory dossiers.Coordination with DRAP and other regulatory bodies.Ensuring product compliance with regulatory requirements.Job Type: Full-timeWork Location: In person

Assistant Manager/Deputy Manager Regulatory Affairs

RECH INTERNATIONAL

Regulatory Affairs Officer - KarachiThe Regulatory Affairs Officer ensures compliance with DRAP regulations for licensing, registration, and marketing of medical devices, acting as the key link between Rech International and regulatory authorities.Job Type: Full time - OnsiteWorking hours: 9am - 6pmWorking Days: Monday - SaturdayMarket Competitive Salary &amp; BenefitsKey Responsibilities:<ul><li>Prepare, submit, and follow up on DRAP registration/notification dossiers.</li><li>Manage licensing of medical devices (Orthopedic Implants, OMF, Neuro, Spine, Knee &amp; Hip Joints).</li><li>Liaise with DRAP officials and internal stakeholders to ensure timely approvals.</li><li>Monitor and implement changes in DRAP regulations, keeping records updated.</li><li>Ensure compliance of product portfolio with DRAP guidelines and legislation.</li><li>Provide regulatory input, reporting, and support for internal teams and external partners.</li></ul>Qualifications &amp; Experience:<ul><li>Bachelors degree in Sciences; Masters preferred.</li><li>3-4 years experience in Regulatory Affairs with DRAP submissions.</li><li>Strong knowledge of DRAP laws and guidelines for medical devices.</li><li>Proficiency in MS Office &amp; Google Apps.</li><li>Excellent communication, analytical, and documentation skills.</li></ul>Job Type: Full-timePay: Rs40,000.00 - Rs80,000.00 per monthApplication Question(s):<ul><li>What is your current salary ?</li><li>How soon can you join?</li><li>What is your salary expectation?</li><li>Do you have experience of DRAP?</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>Regulatory affairs: 2 years (Required)</li></ul>Work Location: In person

Regulatory Affairs Executive

AMICO Group

<div>
 
 Job Purpose
 
 
 
 Under general direction of the Regulatory Affairs Manager, the RA Specialist will do the required registrations on line and all related job requirements including communication with both teams at the supplier's side and inside Amico.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Understanding the registration requirements for several countries
 </li>
 <li>
 Requesting suppliers to provide different documents required for the registration
 </li>
 <li>
 Feeding the different governmental systems with the required registration information and uploading needed documents.
 </li>
 <li>
 Understanding the Comments received from the Authorities on any registration and passing it to the supplier in an easy understandable manner.
 </li>
 <li>
 Attending Conference calls with suppliers, prioritizing the requirements, conveying the needed tasks in an understandable manner
 </li>
 <li>
 Maintaining the Archive system
 </li>
 <li>
 Ability to bridge the communications between Authorities/our local agents in the countries with the supplier
 </li>
 <li>
 Follow the internal regulations in Amico
 </li>
 <li>
 Other regulatory activities such as classification, prequalification and recalls
 </li>
 <li>
 Communicating with the legal department in Amico for all legal concerns.
 </li>
 <li>
 Update the SOPs related to our processes when needed
 </li>
 <li>
 Close follow up for all pending issues
 </li>
 <li>
 Preparing reports related to the progress of work
 
 
 </li>
 </ul>
 
 Job Requirements
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree or equivalent in Science, Pharmacy, Biomedical Engineering, Business Administration or Legal
 </li>
 <li>
 3 years of experience in Regulatory Affairs with regional company (wide range of products)
 </li>
 <li>
 Worked for Medical Device Registration outside Egypt or to register Egyptian products with other countries
 </li>
 <li>
 Excellent Knowledge of MS Office.
 </li>
 <li>
 Fluent in English language
 </li>
 <li>
 Knowing the Pharmaceutical registration process
 </li>
 <li>
 Previous experience in registrations in the Gulf will be an added value
 </li>
 <li>
 Having a certificate in Quality or Regulatory Affairs will be an added Value
 
 
 </li>
 </ul>
 
 Why Join Us
 
 
 
 
 At AMICO, we believe in fostering a diverse and inclusive workplace. We recognize the value that different perspectives and experiences bring to our company.
 
 
 
 
 As part of our commitment to diversity, we encourage applications from all individuals as part of our inclusive hiring practices.
 
 
 
 
 This initiative is part of our broader diversity agenda aimed at creating a balanced and innovative workforce
 
</div>

Regulatory Affairs Specialist

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