Senior Manager

The Senior 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 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.

• Change control assessment including variation classification for EU/EU territory and provision of submission requirements
• Authoring of CTD sections (M2.3 and M3) for EU and EU territory, incl. liaising with internal and external stakeholders
• Represent EU RACMC function in global internal and external teams and provide RA CMC guidance and strategy to project teams
• Empowered decision maker for regulatory strategy and submission content
• Develop holistic regulatory submission strategies for life-cycle management considering prioritization of activities, identification of risks and implementation of risk mitigations
• 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

• Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
• Minimum of 5 years of experience in the pharmaceutical industry
• Minimum of 3 years of experience in global regulatory affairs CMC with proven track record in managing RACMC related life-cycle management activities for EU/EU-territory for small molecules products
• Strong RACMC knowledge for both drug substance and drug product
• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
• 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 working knowledge of Microsoft Office

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-