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Regulatory Affairs Manager - Pharma or Combination Products

Regulatory Affairs Manager - Pharma or Combination Products

Job Title: Regulatory Affairs Manager - Pharma or Combination Products
Contract Type: Permanent
Location: Berlin, Germany
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: DJ 900123_1502188187
Contact Name: Daniel Perkins
Contact Email: d.perkins@sciproglobal.de
Job Published: August 08, 2017 11:29

Job Description

I am currently in the search for a Regulatory Affairs Manager with experience in the Pharmaceutical (Combination Product) sector

Your tasks

  • Approval strategies for combi products

  • Maintenance of existing approvals for combi products

  • Variation notifications

  • Choice of new drug suppliers

  • Interface management to health authorities both inside and outside Europe, but also globally

  • Creation and maintenance of Common Technical Documents for Combination Products (eCTD)

  • Consult the responsible R & D managers in the development and validation of new combination products

  • Independent updating / development and implementation of measures for new requirements for combination

products at home and abroad

your qualification

  • Successfully completed pharmaceutical or natural sciences studies or equivalent qualification

  • Several years of professional experience in the authorization of pharmaceutical products or combination products

  • Sound knowledge in the creation of eCTDs

  • Negotiation skills and communication skills

  • Strategic, analytical, entrepreneurial thinking

  • Very good knowledge of English in spoken and written English

  • Ability to work with MS Office

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