regulatory manager

Amazon.com

<div><h2 class="jobSectionHeader">DESCRIPTION</h2><div>
Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. We are driven by the excitement of building technologies, inventing products, and providing services that transform lives. We embrace new ways of doing things, make decisions quickly, and are not afraid to fail. We have the scope and capabilities of a large company, and the spirit and heart of a small one. 
Role Overview 
We are seeking an experienced Senior Compliance Manager to lead our compliance program across UAE and support the AMET (Africa, Middle East, and Turkey) region when needed. In this role, you will develop and implement compliance strategies that protect Amazon's reputation, customers, and business operations while enabling continued growth in diverse regulatory environments. You will collaborate with senior leadership, and serve as the primary point of contact with regulatory authorities across the region. 
 
About the team 
We are a diverse, upbeat, creative and passionate, team. We are owners of our scope and results oriented. We are empowered to adapt our timeline to our personal needs if needed for a better work/life balance. 
GES Values: 
<ul><li>SAFETY FIRST. We continuously seek improvement and innovation in Safety, raising the bar above industry norms and setting a new global standard.</li><li>PEOPLE OBSESSION. We understand the value of listening, promote diversity, lead by example and work together to achieve more, while remembering to have fun.</li><li>CHALLENGE THE NORM. We challenge each other and the industry to try new methods of working, and make a SAFER and more SUSTAINABLE environment. We are human, and not afraid to learn from our mistakes, and keep going!</li><li>MAKE AN IMPACT. We leverage efficient time management to ensure capacity for HIGH QUALITY execution alongside INNOVATION and Thinking Big.</li><li>TRUST. We build trust with our Customer, making ambitious but realistic commitments.</li></ul></div><h2 class="jobSectionHeader">
BASIC QUALIFICATIONS</h2><ul><li>Bachelor's degree in Law, Business, Finance, or related field</li><li>8+ years of professional experience in compliance, regulatory affairs, or legal roles</li><li>Demonstrated experience developing and implementing compliance programs in the AMET region, with specific expertise in UAE regulatory frameworks</li><li>Experience engaging with regulatory authorities and managing regulatory relationships</li><li>Strong understanding of e-commerce, digital services, or retail compliance requirements &bull; Excellent written and verbal communication skills in English</li><li>Proven ability to influence without authority across multiple levels of an organization</li><li>Experience managing budgets and resources for compliance programs</li></ul><h2 class="jobSectionHeader">
PREFERRED QUALIFICATIONS</h2><ul><li>Speak, write and read fluently in either of these preferred languages: French, Polish, Arabic, Turkish, Afrikaans, Zulu and Portuguese.</li><li>Master's degree or professional qualification in Law, Compliance, or related field with 8+ years of experience in compliance roles with progressive responsibility</li><li>Experience with multiple regulatory frameworks across AMET countries</li><li>Experience in a multinational corporation with complex regulatory requirements</li><li>Professional certifications such as CCEP or equivalent</li></ul> 
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you&rsquo;re applying in isn&rsquo;t listed, please contact your Recruiting Partner.</div>

Regulatory/Compliance Manager

Gilead Sciences

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 
 
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 
 
 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
 
 
 
 Job Description
 
 
 
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
 
 
 
 Knowledge &amp; Details
 
 
 
 <ul>
 <li>
 Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
 </li>
 <li>
 Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
 </li>
 <li>
 Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
 </li>
 <li>
 Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
 </li>
 <li>
 Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
 </li>
 <li>
 Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
 </li>
 <li>
 Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
 </li>
 <li>
 Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
 </li>
 <li>
 Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
 </li>
 <li>
 Actively contribute to local and global initiatives that improve regulatory processes.
 
 
 </li>
 </ul>
 
 Professional Experience / Key Skills
 
 
 
 <ul>
 <li>
 Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
 </li>
 <li>
 Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
 </li>
 <li>
 Proven ability to prioritize, conduct, and manage time to meet project deadlines.
 </li>
 <li>
 Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
 </li>
 <li>
 Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
 </li>
 <li>
 Strong focus on achievement of goals and continuous improvement
 </li>
 <li>
 Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
 </li>
 <li>
 Having excellence in multiple project management, good communication and interpersonal skills.
 </li>
 <li>
 Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
 </li>
 <li>
 Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
 </li>
 <li>
 Fluency in spoken and written English.
 </li>
 <li>
 Good decision-making skills are important.
 </li>
 <li>
 Excellent verbal, written, organization skills and interpersonal communication skills required.
 
 
 </li>
 </ul>
 Equal Employment Opportunity (EEO)
 
 
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 
 
 
 For Current Gilead Employees And Contractors
 
 
 
 Please apply via the Internal Career Opportunities portal in Workday.
</div>

Regulatory Affairs Manager

PaxeraHealth

<div>
 Job Description:
 
 
 <ul>
 <li>
 Compliance Management
 </li>
 <li>
 Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies
 </li>
 <li>
 Lead efforts to obtain and maintain certifications (e.g., ISO 9001,ISO 27000, ISO 13485, FDA , MDR, and other relevant quality/compliance standards)
 </li>
 <li>
 Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement
 </li>
 <li>
 Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings
 </li>
 <li>
 Monitor and interpret changes in laws, regulations, and industry standards; advise management on compliance implications
 </li>
 <li>
 Quality Assurance
 </li>
 <li>
 Implement and manage the company&rsquo;s Quality Management Systems (QMS)
 </li>
 <li>
 Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks
 </li>
 <li>
 Conduct regular internal audits and assessments to evaluate compliance and certification readiness
 </li>
 <li>
 Drive continuous improvement in quality processes through monitoring, feedback, and corrective action
 </li>
 <li>
 Risk Management &amp; Reporting
 </li>
 <li>
 Develop and implement a risk management strategy to address potential non-compliance or quality issues
 </li>
 <li>
 Maintain a compliance and certification risk register, ensuring risks are documented and mitigated
 </li>
 <li>
 Monitor and report on the company&rsquo;s compliance status, providing regular updates to senior leadership
 </li>
 <li>
 Investigate and resolve compliance-related issues or incidents, ensuring thorough root-cause analysis and preventive measures
 </li>
 <li>
 Collaboration &amp; Leadership
 </li>
 <li>
 Partner with operations, product, and cross-functional teams to embed compliance into daily workflows
 </li>
 <li>
 Act as the primary liaison for regulatory bodies, certification auditors, and external inspections
 </li>
 <li>
 Provide training, awareness programs, and guidance to employees on compliance standards, policies, and regulatory requirements
 </li>
 <li>
 Foster a culture of integrity, accountability, and continuous learning across the organization
 </li>
 <li>
 Process Improvement
 </li>
 <li>
 Lead continuous improvement initiatives to streamline compliance and certification processes
 </li>
 <li>
 Enhance efficiency by automating and simplifying compliance workflows where possible
 </li>
 <li>
 Stay updated on new regulations, compliance frameworks, and industry trends to anticipate and prepare for potential business impacts
 </li>
 <li>
 Benchmark internal processes against best practices and recommend process optimizations
 
 
 </li>
 </ul>
 
 Qualifications and Skills:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in compliance, regulatory affairs, business administration, or related field
 </li>
 <li>
 At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry
 </li>
 <li>
 Strong knowledge of industry regulations, quality standards (ISO), and compliance processes
 </li>
 <li>
 Experience with obtaining ISO 9001,ISO 27000, ISO 13485, FDA , MDR
 </li>
 <li>
 Excellent English Language
 </li>
 <li>
 Excellent organizational, leadership, and communication skills
 </li>
 <li>
 Ability to manage multiple projects and deadlines in a fast-paced environment
 
 
 </li>
 </ul>
 Powered by JazzHR
 
 
 lLACjXFSu3
</div>

Regulatory & Compliance Manager

<div><h3 class="jobSectionHeader">Job Description: 
 
1. Compliance Management</h3><ul><li>
Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies.</li><li>
Lead efforts to obtain and maintain certifications (e.g., ISO 9001,ISO 27000, ISO 13485, FDA , MDR, and other relevant quality/compliance standards).</li><li>
Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement.</li><li>
Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings.</li><li>
Monitor and interpret changes in laws, regulations, and industry standards; advise management on compliance implications.</li></ul><h3 class="jobSectionHeader">
2. Quality Assurance</h3><ul><li>
Implement and manage the company&rsquo;s Quality Management Systems (QMS).</li><li>
Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks.</li><li>
Conduct regular internal audits and assessments to evaluate compliance and certification readiness.</li><li>
Drive continuous improvement in quality processes through monitoring, feedback, and corrective action.</li></ul><h3 class="jobSectionHeader">
3. Risk Management &amp; Reporting</h3><ul><li>
Develop and implement a risk management strategy to address potential non-compliance or quality issues.</li><li>
Maintain a compliance and certification risk register, ensuring risks are documented and mitigated.</li><li>
Monitor and report on the company&rsquo;s compliance status, providing regular updates to senior leadership.</li><li>
Investigate and resolve compliance-related issues or incidents, ensuring thorough root-cause analysis and preventive measures.</li></ul><h3 class="jobSectionHeader">
4. Collaboration &amp; Leadership</h3><ul><li>
Partner with operations, product, and cross-functional teams to embed compliance into daily workflows.</li><li>
Act as the primary liaison for regulatory bodies, certification auditors, and external inspections.</li><li>
Provide training, awareness programs, and guidance to employees on compliance standards, policies, and regulatory requirements.</li><li>
Foster a culture of integrity, accountability, and continuous learning across the organization.</li></ul><h3 class="jobSectionHeader">
5. Process Improvement</h3><ul><li>
Lead continuous improvement initiatives to streamline compliance and certification processes.</li><li>
Enhance efficiency by automating and simplifying compliance workflows where possible.</li><li>
Stay updated on new regulations, compliance frameworks, and industry trends to anticipate and prepare for potential business impacts.</li><li>
Benchmark internal processes against best practices and recommend process optimizations.</li></ul><div>
Qualifications and Skills:<ul><li>
Bachelor&rsquo;s degree in compliance, regulatory affairs, business administration, or related field.</li><li>
At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry.</li><li>
Strong knowledge of industry regulations, quality standards (ISO), and compliance processes.</li><li>
Experience with obtaining ISO 9001,ISO 27000, ISO 13485, FDA , MDR.</li><li>
Excellent English Language.</li><li>
Excellent organizational, leadership, and communication skills.</li><li>
Ability to manage multiple projects and deadlines in a fast-paced environment.</li></ul></div>
lLACjXFSu3</div>

Client of Aventus Global Talent

Key Responsibilities
<ul>
<li>Support the development, implementation, and monitoring of compliance programs, policies, and procedures to ensure adherence to local and international regulatory requirements.</li>
<li>Review and assess regulatory updates, circulars, and guidance, advising management on implications and required actions.</li>
<li>Assist in preparing and submitting regulatory reports, filings, and notifications within required timelines.</li>
<li>Conduct compliance monitoring, testing, and reviews across business units to identify gaps and ensure corrective actions are implemented.</li>
<li>Support regulatory inspections, audits, and examinations, including gathering documentation and coordinating responses.</li>
<li>Provide compliance advisory support to internal stakeholders on new products, business initiatives, and regulatory obligations.</li>
<li>Assist in the design and delivery of compliance training to staff, promoting awareness of regulatory obligations and ethical standards.</li>
<li>Escalate potential breaches or issues of non-compliance, maintaining accurate compliance records and reporting to senior management.</li>
</ul>
Key Requirements
<ul>
<li>Professional certification in compliance (e.g., ICA, ACAMS, or equivalent) is preferred.</li>
<li>5+ years experience in regulatory compliance within banking, fintech, or financial services.</li>
<li>Good knowledge of UAE Central Bank regulations and an understanding of international compliance frameworks.</li>
<li>Strong analytical and problem-solving skills with attention to detail.</li>
<li>Effective communication and stakeholder management abilities, both written and spoken.</li>
<li>Ability to work independently while contributing to a collaborative team environment.</li>
</ul>

Regulatory Compliance Manager

<div>Site Name: UK &ndash; London &ndash; New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw 
Posted Date: Oct 27 2025 
Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines?
Join our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide.
As part of the CMC Regulatory Affairs team, you&rsquo;ll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support lifecycle management of marketed small molecules. In this exciting role, you&rsquo;ll help shape regulatory strategies, drive sustainability initiatives that align with GSK&rsquo;s 2030 environmental goals, and deliver high-impact solutions that enhance the way we manufacture and control our medicines.
To succeed in this role, you&rsquo;ll be a proactive, motivated individual with experience navigating complex regulatory environments. You will thrive in cross-functional settings, demonstrating excellent people skills and the ability to build strong relationships with diverse stakeholders. Your communication skills will be critical in resolving ambiguous or complex challenges, and your open-minded, adaptable approach will set you apart as a leader in regulatory strategy.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
In this role you will:<ul><li>
Develop and deliver regulatory strategies for global, regional, and local market submissions, ensuring compliance with evolving regulations and scientific standards.</li><li>
Provide expert guidance to multidisciplinary teams on regulatory requirements, policies, and guidelines related to the manufacture and control of medicinal products.</li><li>
Support lifecycle management submissions, ensuring alignment with regional requirements and minimizing questions from Health Authorities.</li><li>
Collaborate in cross-functional matrix teams working closely with Regulatory, Development, Quality, Technical, and Manufacturing stakeholders to define effective regulatory filing strategies.</li><li>
Ensure continuity of market supply by managing regulatory aspects of product release.</li><li>
Drive innovation and continuous improvement to respond to the evolving regulatory environment.</li><li>
Share best practices and learnings across the CMC Regulatory teams and other impacted functions to enhance regulatory compliance and efficiency.</li></ul>
Why you?
Basic Qualifications &amp; Skills:
We are looking for a professional with these required skills to achieve our goals:<ul><li>
Bachelor&rsquo;s degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.</li><li>
Proven experience in CMC regulatory affairs or product development, including preparation of regulatory submissions for late-phase development and/or marketed product lifecycle management.</li><li>
Strong understanding of drug development, manufacturing processes, and supply chain.</li><li>
Knowledge of global CMC regulatory requirements, with a track record of delivering complex regulatory strategies and overseeing submission writing.</li><li>
Excellent time management skills and the ability to prioritize multiple tasks in a fast-paced environment.</li></ul>
Preferred Qualifications &amp; Skills:
If you have the following characteristics, it would be a plus:<ul><li>
Master&rsquo;s or Ph.D. degree (or equivalent) in pharmacy, chemistry, or a related scientific discipline.</li><li>
Regulatory Affairs Certification (RAPS) or equivalent professional certification.</li><li>
Demonstrated expertise in influencing and negotiating with internal teams and regulatory agencies.</li><li>
Experience implementing regulatory strategies that impact global projects and product plans.</li><li>
Strong interpersonal, presentation, and communication skills, with a proactive approach to process improvement.</li><li>
Recognized as a CMC Regulatory expert in a specific subject area, with the ability to lead through continuous change and improvement.</li></ul>
At GSK, we&rsquo;re committed to improving the quality of human life by enabling people to do more, feel better, and live longer. As a CMC Regulatory Project Manager, you&rsquo;ll contribute to this mission while advancing your career in an environment that fosters collaboration, innovation, and professional growth.
Join us to help shape the future of healthcare and make a difference in the lives of patients worldwide.
Closing Date for Applications: 10th November 2025 (EOD)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the &lsquo;cover letter&rsquo; of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people&rsquo;s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients&rsquo; needs and have the highest probability of success. We&rsquo;re uniting science, technology, and talent to get ahead of disease together.
Find out more: 
Our approach to R&amp;D
Why GSK? 
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK&rsquo;s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/</div>

CMC Regulatory Project Manager

IQVIA

No visa or accommodation sponsorshipYou will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.JOB OVERVIEWEssential Functions<ol><li>Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.</li><li>Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.</li><li>Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.</li><li>Artwork review and approval in client systems.</li><li>Manage multiple pharmaceutical products.</li><li>Act as subject matter expert in regulatory processes.</li><li>Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.</li><li>Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.</li><li>Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.</li><li>Project budget management.</li><li>Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.</li><li>Possible exposure to present to clients on complex regulatory processes and bid defense meetings.</li><li>Act as reviewer for regulatory standard operating procedures.</li><li>Prepare and deliver internal regulatory training if required.</li></ol>MINIMUM REQUIRED EDUCATION AND EXPERIENCEExperience: Typically requires 8-10 years of prior relevant experience.Education: Masters Degree in Life Sciences or related discipline.Skills and Abilities:<ul><li>Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.</li><li>Possesses specific regulatory or technical expertise.</li><li>Interpersonal communication (oral and written) and organization skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li><li>Demonstrates self-motivation and enthusiasm.</li><li>Ability to adapt quickly to a rapidly changing environment.</li><li>Knowledge of Maintenance of Marketing Authorization.</li><li>Experience of preparing variation renewal packages and artwork approvals.</li><li>Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.</li><li>Must be fluent in Arabic.</li></ul>IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at

Global Regulatory Affairs Manager (homebased)

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Global Regulatory Affairs Manager (homebased)