The Sr. Director, Pharmaceutical Affairs - France will have the opportunity to lead the regulatory strategy within the local affiliate (France).
This is a newly created role intended for a forward looking, creative and agile Sr Director of Pharmaceutical Affairs able to anticipate and address the challenges involved in supporting the interactions with the regulatory authorities for the assigned region/countries for messenger RNA therapeutics as unprecedented new drug modality. The Sr Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases, Oncology, Cardiovascular and Rare diseases and, as a secondary role, will also act as the local Responsible Pharmacist (pharmacien responsable).
Their support includes but is not limited to managing the regulatory interactions with the local regulatory authority (ANSM) in France. This person will work closely with the business in the country affiliate to provide the regulatory guidance to support the overall business plans, review of promotional and non-promotional materials as well as support to market access from regulatory perspective in reimbursement/pricing discussions.