Germany_Senior Associate Regulatory Affairs (m/f/d)
Core
Senior Associate Regulatory Affairs ensuring regulatory compliance throughout the product lifecycle and supporting efficient implementation of global regulatory strategies at the national level.
Role type
Senior Associate Regulatory Affairs
Builds
Regulatory documents (SmPCs, Patient Information Leaflets, Blue Box), product information texts, artworks, and external database entries.
Domain
Biopharmaceuticals / Biosimilars
Required skills
Regulatory compliance, product lifecycle management, document preparation, database management, regulatory monitoring, cross-functional collaboration, artwork management, filing and archiving
Preferred skills
Experience with regulatory information systems, international stakeholder engagement
Technologies
Rote Liste, Gelbe Liste, ABDATA, ifap, IFA, MS Office
Responsibilities
Review and maintenance of product information texts and artworks; prepare Blue Box information; support global regulatory activities; update and maintain regulatory documents (SmPCs, PILs, safety data sheets); track implementation of updated product information; monitor regulatory developments and trends; provide regulatory updates to internal stakeholders; manage external databases and portals; ensure compliance with internal and external standards; maintain standardized filing and archiving systems.
Seniority
Senior, hands-on IC