Germany_Senior Associate Regulatory Affairs (m/f/d)

Key Responsibilities

• Close cooperation with the Global Regulatory Affairs team and implementation of global regulatory guidelines at national level

• Review and maintenance of product information texts, artworks and preparation of Blue Box information

• Support of global regulatory activities to ensure efficient, compliant business processes in collaboration with cross-functional teams

• Contribution to the preparation of educational and training materials

• Support the update, implementation and maintenance of all regulatory-relevant documents and materials at national level, ensuring timely availability

• Preparation and maintenance of regulatory documents such as SmPCs, Patient Information Leaflets, mandatory texts, Blue Hand materials, safety data sheets and batch release waivers

• Tracking the implementation and use of updated product information by internal teams and external service providers

• Maintenance and update of external databases and portals (e.g. Rote Liste, Gelbe Liste, ABDATA, ifap, IFA)

• Monitoring regulatory developments, new requirements and trends, including screening of authority newsletters and product websites

• Providing regulatory updates and ensuring effective information flow to internal stakeholders (Market Access, Medical, Marketing, Quality)

• Artwork management and lifecycle management of product information

• Ensuring compliance with internal and external regulatory standards

• Close cross-functional collaboration with Quality, SCM, Medical, Pharmacovigilance, Market Access and Marketing

• Maintenance of a clear and standardized filing and archiving system for regulatory documents and correspondence