Manager Regulatory CMC (f/m), Lyon

Notre passion pour la science et la technologie anime nos quelque 62 000 collaborateurs répartis dans 65 pays, qui s’attachent à relever certains des défis les plus complexes de notre époque et à développer des modes de vie plus durables.

Dans un monde en mutation rapide et incertain, des facteurs tels que le vieillissement de la population, les maladies chroniques, l’intelligence artificielle, le changement climatique et d’autres mégatendances ont suscité un besoin de percées scientifiques capables d’apporter une contribution positive à l’ensemble de notre société mondiale. Le rythme du changement va s’accélérer au cours des prochaines décennies, à mesure que les technologies évoluent et convergent de manière à transformer en profondeur notre façon de vivre et de travailler. Pour nous, chez Merck, le changement n’est pas une menace, mais une opportunité, comme nous l’avons prouvé depuis plus de 350 ans.

Your role

• As an individual contributor in our organization, your role is crucial for developing and executing the Global Regulatory Chemistry Manufacturing and Control (CMC) strategy for Life Cycle Management programs. The ideal candidate will have a strong background in regulatory affairs, particularly in CMC, and should demonstrate excellence in designing CMC regulatory strategy and dossier strategy for various projects and products.
• Your role involves developing and managing the Global Regulatory CMC strategy for assigned projects/products across various regions. Responsibilities include overseeing regulatory CMC activities to ensure timely delivery and quality compliance, as well as authoring and maintaining the CMC Dossier Strategy Document and related registration dossier (NDA/MAA, variations, etc.). The role will provide regulatory CMC expertise to key stakeholders, ensuring adherence to country-specific requirements and evaluating Change Control proposals.
• Given the significant business impact and dynamic life-cycle management environment, your role is high-demand, and fast-paced. It involves managing critical business topics, necessitating resilience and learning agility.

Profile

• You have a Degree in a Life Science or related discipline (e.g., MSc or equivalent degree; PhD in a scientific discipline is preferred), a minimum of 5 years of pharmaceutical industry experience, with at least 2 years of experience in Global regulatory affairs (GRA) related to Chemistry Manufacturing and Control (CMC).
• You possess a strong ability to develop and prepare successful regulatory CMC strategies and dossiers.
• You have extensive experience in the preparation and management of regulatory CMC documentation, including full international submissions and large variations.
• You hold practical experience in manufacturing process development, transfers, validation, or analytical development and control strategies.
• You have in-depth knowledge of global pharmaceutical legislation and regulatory affairs.
• Your excellent written and spoken communication skills in English are complemented by knowledge of other European languages, such as French and German.
• You are strategic in your thinking, detail-oriented, and possess excellent organizational and planning skills.