My client, a leading global pharmaceutical manufacturing organisation are looking for a Head of Regulatory Affairs with experience in Generics
Title: Head of Regulatory Affairs
- Management of the Regulatory Affairs department including the areas of Maintenance, Generic Reauthorization and Artwork.
- Assumption of the position of Information Officer according to 74a AMG (German Drug Law)
- Ensuring the smooth and correct processing of all tasks in the area of Regulatory Affairs
- Analysis, optimization and implementation of cross-departmental business processes; planning and independent project execution, cross-departmental coordination; intensive internal interface and communication management
- Close cooperation with the individual branches in the area of Regulatory Affairs as well as with the Corporate Regulatory Affairs team
- Answering the technical parts of regulatory inquiries with the corresponding regulatory correspondence
- Tracking of national and European legal bases and regulatory requirements including assessment of relevance for our company's drug approvals
- Participation in strategic product planning
- Product launches
- Regular reporting
- Analysis of market development
- Collaboration with the launch management, portfolio management and in-licensing departments
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call +49 6995179969 for a confidential discussion about potential opportunities.
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