Regulatory Affairs Manager Job – Central London

My client are a large CRO based in Central London that work across all phases of the drug development process. They are looking to take on a Regulatory Affairs Manager with strong leadership and technical skills.

 

Responsibilities:

  • Provide expert regulatory advice to colleagues.
  • Ensure submissions are accurately compiled.
  • Take part in business development activities including preparing regulatory sections of proposals and feasibility reports.
  • Liaise with the Regulatory Director to plan, organise and compile regulatory submissions.
  • Coordinate and manage regulatory and ethics submissions through the EMA, Asia Pacific and Latin America regions.
  • Review and make recommendations on relevant regulatory documents including labels, SmPCs to ensure compliance with ICH guidelines.

 

Person specification:

  • Previous experience working in a CRO environment.
  • Line management experience.
  • Strong planning, strategising, monitoring and critiquing skills.
  • Strong interpersonal skills in a fast paced, deadline orientated and challenging environment.
  • Excellent self motivation skills.
  • Make decisions independently.

 

Application details:

For more information, or to apply for this Regulatory Affairs Manager position, please contact Meera Pattni on 01438 743 047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Regulatory Affairs Manager position online now.

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