1+ months

Regulatory Affairs Manager GCMC

Pfizer
Elsene
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Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.



GCMC (Global Chemistry, Manufacturing and Control) is committed to support Biotherapeutic Pharmaceutical Science (BioTX PharmSci) and Pfizer Global Supply (PGS) as competitive advantage for Pfizer by consistently delivering high quality regulatory strategies and timely submissions across product lifecycle.GCMC is fully engaged in drug development, product line extensions and maintenance. GCMC representatives participate on teams and at sites as GCMC experts and overall advocate for effective drug development and maintenance paradigms.



**Role description**



**Be responsible for execution of Regulatory Strategies for Vaccines and Biotechnological Products.**



Contributes to the development and execution of European Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's,...) to regulatory agencies. Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides.Acts as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.



Leads the preparation of CMC information for submission to EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans, including major, complex applications. Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Interfaces directly with Boards of Health, including scientific reviewers, administrative staff,... in order to discuss and define regulatory applications (Quality Module, Responses, Commitments. Acts as CMC representative in formal meetings and teleconferences with regulatory authorities.



Acts as the EU CMC representative and contributes support to the Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.



Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products.



This position can be taken up from four possible locations: **Belgium, Brussels; Ireland, Grange Castle; UK, Walton Oaks or Spain, Algete.**



**Qualifications**



+ Regulatory **CMC** experience OR regulatory expertise in pharmaceutical science development OR **biopharmaceutical** manufacturing OR specific regulatory domain.

+ Functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

+ Fluency in English is essential.

+ Influencing and persuading skills.

+ Cross-cultural awareness and understanding.



**What we can offer you**



You will have on-the-job training within a highly skilled team.



In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.



Working at Pfizer means that you will be working towards breakthroughs that change patients' lives.



Pfizer's values : Excellence, Courage, Equity and Joy.



Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.



We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that's what we strive for and live by. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



We offer possibilities for homeworking and flexible working hours.



Possible locations : Belgium, Brussels; Ireland, Grange Castle; UK, Walton Oaks or Spain, Algete.



For this position we do not offer relocation.



\#LI-REMOTE



Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.



Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2)Elsene, the Belgian headquarters, 3)Puurs, Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center.



More information can be found atwww.pfizer.com,www.pfizer.beand on Facebook and Twitter.



Regulatory Affairs
Posted: 2021-05-06 Expires: 2021-06-28
Sponsored by:
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Regulatory Affairs Manager GCMC

Pfizer
Elsene

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