Manager Regulatory Affairs CMC

Manager Regulatory Affairs CMC

Daiichi Sankyo Europe

Munich, Germany

The position:

The Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent EU Regulatory Affairs CMC in internal and external interactions (e.g. global and local project teams, working teams, authorities’ communication, CMOs).

A key focus area of the position is the preparation of regulatory CMC documentation for small molecule products during development and commercial stage, in a manner that is scientifically sound, commercially viable and in accordance with current regulatory CMC standards.

Further, it is the goal of the role to translate latest EU and international regulatory CMC requirements into state of the art, high-quality regulatory CMC documentation, develop EU and international regulatory submission strategies, author dossiers, and technical documents.

Roles and responsibilities:

• Review CMC documents and develop regulatory strategies for development and life cycle of the products;
• Lead authoring of CTD sections (CMC-relevant part of M1, M2.3 and M3) for EU/CH/UK, incl. 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.

Personal skills and professional experience:

• 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 years 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.