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Head of RA


  Munich,   130K

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  Regulatory Affairs    Permanent

Vacancy Details

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

Salary: Competitive

Location: Munich

 

Responsibilities:

  • 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.

 

Joe.Lane

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