Sr. Associate/ Manager Regulatory Affairs (m/w/d)

  • Munchen, Germany
  • Full-time
  • Department: Regulatory
  • Region: EU+/Canada

Job Description

For our office in Munich we are right now recruiting for an:

Sr. Associate/ Manager Regulatory Affairs (m/w/d)

This is a  limited term contract for 18 months 

 

Main Responsibilities:

  • Collaborate in development, implementation and maintenance of Regulatory Affairs relevant compliance documentation such as e.g. Policies and SOPs
  • In collaboration with other RA staff, manage surveillance of all licensing-related procedures (e.g. translation and communication of Dear Doctor Letters, Approval extension, Amendments of SmPC and PIL, etc) and realization of international regulatory specification
  • Collaborate in ensuring maintenance of regulatory-related documentation including updates of SmPCs for BIIB products into local electronic databases
  • In collaboration with other RA staff, manage transfer of licensing-related knowledge/know-how within the department across departments and divisions
  • Ensure maintenance of regulatory-related documentation including updates of SmPCs for BIIB products into local electronic databases
  • In collaboration with other RA staff, manage liaison with regional and global regulatory groups on changes to local labeling
  • Collaborate in Regulatory relevant aspects of medicinal products under marketing authorization holder ship of the affiliate
  • Assist in management of initial generation of German versions of SmPCs, PILS and labelling of medicinal products registered / intended to be registered following the national / centralized procedures
  • Support various department members in their day-to-day activities such as material review

Qualifications

  • 2-5 years working experience in the Regulatory field of the (bio)pharmaceutical industry, whereas the master degree in RA (M.D.R.A.) counts as working experience.
  • Versed in MS-Office, web applications, Regulatory relevant databases (e.g. intelligence tools such as Cortellis), as well as in electronic Document Management Systems and electronic review systems
  • University degree in natural sciences (e.g. Pharmacy, Biology, Chemistry) or otherwise adequate vocational training in conjunction with at least 2-5 years working experience in a similar position in the Regulatory field of the (bio)pharmaceutical industry. A master degree in RA counts as working experience.

Additional Information

The main purpose of this job is to add professional Regulatory input to Biogen’s operational daily business under close observation of and compliance with legal, regulatory and company internal rules and regulations (e.g. Policies and SOPs) both on a pan-European or international and affiliate level.

Recognition, documentation and reporting of adverse events and technical product complaints to Drug Safety Germany or the responsible service center according to local SOPs.

The holder of this position shall manage daily business.

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