Vice President

Job Description : VP PHARMA FRANCE This strategic position will lead all CMC (Chemistry, Manufacturing & Controls) activities to support the completion of clinical development and future commercialization of the company's products. What you will do: CMC Strategy and Leadership Develop and implement the overall CMC strategy in support of clinical and commercial development objectives. Collaborate cross-functionally with regulatory affairs, quality, supply chain , clinical and preclinical teams. Contribute to the LCM and industrial protection strategy for products in relation to CMC aspects. Be the CMC expert of reference for regulatory submissions, interactions with health authorities (EMA, FDA, etc.), partners and due diligence activities. Manage internal and external teams involved in CMC projects. Process development and manufacturing Oversee the development, scale-up, technology transfer and manufacturing of active ingredients (APIs) and pharmaceutical forms with CDMOs and CMOs. Ensure process optimization and validations while respecting costs, quality and deadlines. Drive risk management. Regulatory Affairs and Compliance Define the CMC regulatory strategy and contribute to submissions such as IND, IMPD, NDA, etc. Ensure compliance with GMP requirements, ICH guidelines and current regulations (US, EU). Represent the company to the authorities in all matters related to the CMC. Quality and Supply Chain Work closely with quality teams to implement CMC quality processes and supervise industrial partners Contribute to securing the Supply Chain (clinical and commercial equipment). Identify and manage strategic partnerships with CDMOs/CMOs to ensure production continuity. What you will bring: Ideally PhD, PharmD or Master in Chemistry or Pharmaceutical Sciences Significant experience (at least 15 years) onCMC functions, process development and manufacturingwithin the pharmaceutical industry and/or biotechnology companies Proven experience of theproject management in interaction with CDMOs/CMOs(development and manufacturing of active substances and finished products) and inteam management Solid experience indrafting of CMC sections of regulatory files(IND, IMPD, NDA). First experience desiredNDA submission and commercial launches. Good knowledge of standards and regulations (GMP, FDA, EMA, ICH). Experience in a biotech/start-up environment, comfortable in agile and dynamic teams, partially remote. Leadership and strong ability to work cross-functionally. Fluent English and French required.

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