Regulatory CMC Manager
Hobson Prior are in search for a Regulatory CMC Manager to join a leading biopharmaceutical organisation dedicated to the development and manufacturing of innovative biosimilar medicines. This is a permanent position to be either located in Zurich or Reykjavik.
- You will act as the Regulatory representative in cross-functional biosimilar development teams.
- Contribute proactively towards preparation of technical sections of dossiers such as IMPD, IND and Module 3/2.3 of MAA, BLA.
- Close interaction with project management, regulatory operation, manufacturing, quality control and analytical development teams.
- You will provide active support towards regulatory CMC strategy development.
- Partaking in Health Authority meetings and preparation of responses to Health Authority questions (US, EU, global).
- Working with Regulatory Operations for the management of regulatory database.
- Excellent organizational and communication skills (both in written and verbal English).
- Team player.
- You will have a minimum of 3 - 5 years biopharmaceutical industry experience.
- Master's degree in science (pharmacy, biology, chemistry) or higher would be preffered.
- CMC regulatory authoring experience or deep technical expertise and experience writing protocols, reports and technical rationales.
- Proven experience in cross-functional teams.
- Some knowledge of EU and US regulatory is an asset.
- Manufacturing and QA/QC experience is desirable.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€60000.00 - €70000.00 per annum
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