Manager Regulatory Affairs CMC (m/f/d)

Job title: Manager Regulatory Affairs CMC (m/f/d)

About the Role The Manager Regulatory Affairs CMC provides European regulatory CMC guidance and strategy for assigned products and represents EU Regulatory Affairs CMC in internal and external interactions. The role focuses on preparing regulatory CMC documentation for small molecule products across development and commercial stages, translating EU and international requirements into high-quality submissions. The candidate will develop submission strategies and author CTD dossiers and technical documents.

What You'll Do

• Review CMC documents and develop regulatory strategies for development and lifecycle of products.
• Lead authoring of CTD sections (M1, M2.3 and M3) for EU/CH/UK, including liaising with internal and external stakeholders.
• Represent EU RACMC function in global internal and external teams and provide RA CMC strategic guidance to project teams.
• Change control assessment including variation classification for EU/CH/UK and provision of submission requirements.
• Define strategy and respond to Health Authorities queries.
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, and communicate important changes and trends with the relevant stakeholders.
• Participate or lead assigned non-project tasks and process improvements.
• Ensure maintenance of regulatory compliance.

What We're Looking For

• Master degree in Life Science or Pharmacy; PhD preferred; Master Degree in Regulatory Affairs is a plus.
• Minimum of 3 years of experience in the pharmaceutical industry.
• Minimum of 1 year of experience in regulatory affairs CMC with proven track record in managing RACMC related activities for EU/CH/UK for small molecules products.
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization.
• Ideally experience of working in global environment in interdisciplinary teams.
• Solution- and detail-oriented; well organized and self-motivated.
• Excellent written and oral communication skills in English; German as a second language preferred.
• Strong proficiency in Microsoft Office, experience with Veeva is a plus.

Nice to Have

• Experience with Veeva is a plus.

Compensation & Benefits

• Salary not disclosed in posting.