Regulatory Affairs Manager - CMC

Hobson Prior is seeking a Regulatory Affairs Manager - CMC to join a dynamic team in the biotech industry. In this role, you will focus on regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls (CMC). This is an exciting opportunity to contribute to pre-clinical and early-phase projects in a rapidly evolving therapeutic area.

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

Responsibilities:

• Lead the preparation of regulatory documents, including clinical trial applications (CTA), investigational new drug (IND) submissions, and genetically modified organism (GMO) applications.
• Collaborate with various teams to ensure manufacturing and analytical processes meet regulatory standards.
• Provide strategic input on regulatory pathways for complex biologics or biotech products.

Key Skills and Requirements:

• Strong understanding of regulatory processes, particularly in the EU and US.
• Experience with biologics, with a preference for candidates familiar with cell and gene therapy.
• Ability to work effectively across teams and adapt to a fast-paced environment.

For more information, please contact Syem Mannan.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' 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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