Senior Manager - CMC Regulatory Affairs

Daiichi Sankyo, with over 120 years of experience and 19,000 employees across more than 30 countries, dedicates itself to discovering, developing, and delivering new standards of care. In Europe, the focus is on protecting people from cardiovascular disease and driving oncology innovation for solid tumours and blood cancers from Japanese labs. European headquarters are in Munich, Germany, with affiliates in 15 countries and Canada.

The EU Regulatory Affairs CMC function within the Technology Unit leads dossier preparation and maintenance for development and commercial products, submitting to EU and international health authorities. It ensures high quality standards through close interaction with research and manufacturing functions. The goal is maintaining trustful relationships with authorities for on-time drug approvals and patient supply.

The Senior Manager provides European regulatory CMC guidance and strategy for assigned products, representing the function in global project teams, working teams, authorities, and CMOs. Key focus is preparing scientifically sound, commercially viable CMC documentation for small molecule products during commercial stage. Translate latest EU and international requirements into high-quality dossiers and technical documents.

Interact daily with internal stakeholders and external partners to author CTD sections and develop submission strategies. Participate in change control assessments and respond to health authority queries. Stay current with regulations to communicate trends and ensure compliance in lifecycle management.