At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
The function of EU Regulatory Affairs CMC
Within Daiichi Sankyo's Technology Unit, the role of the EU Regulatory Affairs CMC function is to lead the preparatlon and maintenance of dossiers of Daiichi Sankyo's development and commercial products, and to submit to EU and international health authorities. To ensure high quality standards and health authority expectations are met, we are both closely interacting With research and manufacturing functions within Daiichi Sankyo, and aiming to maintain a trustful relationship With health authorities, striving to ensure on-time approval of our drugs and securing patient supply.
The position
The Senior Manager Regulatory Affairs CMC will lead the preparation of regulatory CMC documents for products of diverse modalities (small molecules, biological products or ATMPs) during development and/or commercial Stage in a manner that is scientifically sound, commercially viable and in accordance With current regulatory CMC standards. The position holder 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 (Scientific Advice), CMOs). 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, and review dossiers and technical documents.
Roles and Responsibilities
- Working in regulatory teams to prepare of M2.3 and M3 CTD documents for EU and intemational HA for development and commercial filings
- Represent EU RACMC function in global RACMC and CMC teams and provide RACMC guidance and strategy to project teams
- Review CMC documents, develop regulatory strategies, conduct risk assessments
- Support the preparation and execution of Health Authority meetings
- Interpret, develop strategy and lead response preparation on Health Authorities information requests
- Keep close collaboration With global RACMC colleagues and technical experts across all regions
- 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 5 years of experience in the pharmaceutical industry
- Minimum of 3 years of experience in global regulatory affairs CMC with experience in biologics or small molecules (experience in both preferred)
- 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
- Experience of working in or leading interdisciplinary teams
- Solution and detail-oriented; well organised and self-motivated
- Excellent written and oral communication Skills in English, German as a second language preferred
- Strong working knowledge of Microsoft Office
