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.
- 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
- 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 firstname.lastname@example.org or call 0203 0789 551. A full job description is available on request.