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Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Munich, Bayern
  • Salary: Competitive
  • Job reference: 486473/001_1567677502
  • Sector: EPM Scientific, Regulatory
  • Date posted: 05/09/2019

Regulatory Affairs Manager

A start-up affiliate in the biopharmaceutical area is hiring a Regulatory Affairs Manager to contribute to the development of their European operations from Munich, Germany. You will be responsible for the review of parental biopharmaceutical products for investigational products (phase I-III) and medicinal products in accordance with regulatory authorisations, EU regulatory requirements, applicable quality agreements, and commercial agreements with my clients marketing partners. They are developing medicines focused on immunology, oncology, and metabolic diseases.

Responsibilities

  • Management of operational RA aspects, CMOs and partners

  • Collaborate and liaise with departments for the development of products

  • Reviewing and ensuring documentation is according to international regulatory requirements

  • Prepare and coordinate Regulatory dossiers

Requirements:

  • Degree in Life Sciences

  • Biotech or pharmaceutical background

  • +3 years experience in RA environment

  • CMC knowledge

  • Highly motivated and open-minded team player

  • Fluent in English, written and oral

Benefits

  • Salary: €75,000 - €85,000 base

  • Financial support for relocation

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact +44203758831

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