About the JobAs a GRA CMC Lead within the GRA Regulatory CMC & Devices (Vaccines) department, you’ll lead the management of a portfolio of projects and marketed products, develop CMC regulatory strategies, and represent the company in interactions with global Health Authorities.Main ResponsibilitiesDevelop CMC regulatory strategies and assess associated risks for development projects and/or registered products.Participate in Change Control assessment and ensure robust collaboration within CMC teams for the implementation of defined 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.Take into account requests from Health Authorities in an effective and timely manner and develop lasting relationships with them.Provide support for strategic negotiations with the Global Health Authorities (FDA, EMA) to achieve pragmatic decisions with the greatest probability of success.Draft, review and approve supporting documents for consultation with Health Authorities to define future submission strategy.Coordinate the submission of CMC regulatory files and contribute to their preparation and review.Monitor and manage post‑approval commitments related to CMC activities.Prepare variation files in accordance with requirements,



quality standards and within the allotted time.Author the Global Regulatory CMC Strategy Document in connection with the Blue Print model if applicable.Support the regulatory inspection process and contribute to Sanofi initiatives by reviewing local and international regulations and guidelines.Communicate the requirements of the Health Authorities within the organization.QualificationsExperience : At least 4+ years in a regulatory role within a medium to large organization, with operational experience in a Regulatory CMC department.Knowledge : Global regulations/guidelines, Health Authorities, and their modes of operation and expectations.Skills : Ability to solve strategic technical and regulatory problems; initiative, reflection,foresight and effective communication with internal or external partners.Education : BS/BA in a relevant scientific discipline required; advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Sciences or related field) preferred.BenefitsSalary range: 127,000.00 – 177,000.00 (includes target bonus). Additional benefits include high‑quality health care, prevention and wellness programs, and a comprehensive rewards package.Equal Opportunity EmployerSanofi is an equal opportunity employer committed to diversity and inclusion. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.#J-18808-Ljbffr

📌 Gra Cmc Lead - $127,000 - $177,000 A Year (Winnipeg)
🏢 Sanofi
📍 Winnipeg