27 days ago on proclinical.com

Regulatory Affairs Specialist - 5 months contract

ProClinical AG

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Regulatory Affairs Specialist - 5 months contract

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ProClinical are currently recruiting for a Regulatory Affairs Specialist with a focus on CMC and API submission on behalf of our client. Our client is part of a leading global pharmaceutical organization and specialized in pharmaceuticals and medical devices. The role will be based in the German part of Switzerland and is a 5 month contract.

In this regulatory function you will perform and support activities to ensure regulatory filing compliance as a basis to support the business for APIs manufacturing process.

Job Responsibilities:

  • Submissions, Coordination and preparation for new submissions, regular updates, variations, renewals
  • Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
  • Regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawals
  • Coordination and preparation of responses to deficiency letters or authority requests
  • Regulatory assessments of Change Requests and development of regulatory implementation plan
  • Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
  • Ensure regulatory filing compliance and continued lifecycle management

Job Requirements:

  • A minimum of a Bachelor's degree 
  • Minimum of 6+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry).
  • Regulatory CMC or CMC experience is preferred.
  • Basic knowledge of regulatory requirements is preferred.
  • Drug development experience is preferred.
  • A working knowledge of global HA laws, regulations, and guidance is required.
  • Experience developing regulatory strategies and an understanding of product development is preferred.
  • Knowledge in German is preferred but not absolutely required

If you would like to apply for this role, please send your CV to Beata Klecz on b.klecz@proclinical.ch or call 0203 0789 551. A full job description is available on request.