Hobson Prior are collaborating with a fantastic biotech organisation who are seeking for an individual to join their team on a permanent basis. The current position available at our client's organisation is for a Regulatory Affairs Manager - CMC. Our client is focused on bringing innovative oncology and rare disease therapies to market.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will assist with the alignment of both structure and contents of quality regulatory documentation across company platforms.
• Participate in the development of regulatory CMC method for the designated projects.
• Aid the definition and formation of platform approaches to prepare quality regulatory documentation used in development, registration and post-approval stages.
• Write international quality regulatory documentation for designated project(s) rendering to the pertinent processes in a timely manner.
• Any other assigned duties.

Requirements:

• Know-how and comprehension of scientific principles and regulatory CMC needs pertinent to international drug development.
• Acquaintance with writing regulatory CMC documents for clinical trial applications such as quality parts of INDs/IMPDs, and/or marketing authorisations such as quality parts of variations, BLAs, MAAs, etc.
• Educated to a degree level in a biochemistry, biology, chemistry, pharmacy or similar field.
• Demonstrable experience in international regulatory affairs CMC focusing on Biologics, Vaccines and/or Small Molecules.

Apply now:

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.

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