Head of Regulatory Affairs - CMC

Job Ref: J23887
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 09 October 2017
  • England, UK
  • Competitive
  • Natasha Rollason

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SRG are recruiting for a Global Pharmaceutical organisation who have opened a new vacancy within their Regulatory Affairs team. They are actively seeking to recruit a Head of Regulatory CMC to work at their offices in North East England.

The Role:

Manage the Regulatory team responsible for the production of CMC regulatory information, actively participate in the preparation of CMC regulatory documents and provide CMC regulatory advice to colleagues and clients

Key Responsibilities:

Provide Regulatory leadership for the team engaged in the preparation of Global CMC Regulatory submissions.

Coordinating, producing and reviewing CMC Regulatory Documentation

Participate in meetings with potential CMC Regulatory clients and also assisting in the preparation of proposals.

Provide API and Drug Product related CMC advice to colleagues and clients

Provide regulatory advice and documentation to clients planning to attend Agency meetings and supports RFI's

Skills/Experience Required:

Life Sciences Qualified

Extensive industry experience within Regulatory CMC

Indepth knowledge of small molecule CMC regulatory requirements at all development phases.

Understanding of large molecule regulatory submissions

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.