GRA CMC Lead, Vaccines
- Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
- Participate in Change Control assessment.
- Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
- Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
- Ensure that requests from Health Authorities are taken into account in an effective and timely manner. Develop lasting relationships with the Health Authorities.
- Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
- Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
- Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. To ensure the monitoring and management of post-approval commitments in connection with CMC activities.
- Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted.
- Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable.
- Ensure that CMC regulatory issues are considered and resolved optimally.
- If applicable, support the regulatory inspection process.
- Contribute to Sanofi initiatives, review of local and international regulations and guidelines. Ensure that the requirements of the Health Authorities are taken into account and communicated.
- Operational experience within an organization (medium to large) in Regulatory CMC department
- Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations. Ability to solve strategic technical and regulatory problems. (at least 4 years of experience in Regulatory department)
- Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.
- BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-SP #LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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