Germany_Senior Associate Regulatory Affairs (m/f/d)
Core
Senior Associate Regulatory Affairs ensuring regulatory compliance throughout the product lifecycle and supporting global regulatory strategies at the national level in Germany.
Role type
Senior Associate Regulatory Affairs
Builds
Regulatory compliance and product lifecycle management for biosimilars and innovative biopharmaceuticals
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory compliance, product information management, regulatory document preparation, database management, regulatory trend monitoring, cross-functional collaboration
Preferred skills
Experience with regulatory information systems, international stakeholder management
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 authority newsletters; provide regulatory updates to internal stakeholders; manage external databases and portals; maintain filing and archiving systems
Seniority
Mid-Senior, hands-on IC
