Regulatory Affairs CMC Specialist - Pharmaceutical

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details

Mantell Associates is partnered with a leading Pharmaceutical organisation, who are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.

Regulatory Affairs CMC Specialist - Responsibilities:

  • Contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities
  • Contribute to global regulatory CMC strategies
  • Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation
  • Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them
  • Write/assemble CMC sections of regulatory submissions
  • Develop and maintain project plans and schedules for CMC submissions
  • Ensure all CMC dossiers are stored in the company database
  • Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals
  • Share knowledge and experience with other team members
  • Collaborate with service providers contracted to support a project, if appropriate

Regulatory Affairs CMC Specialist - Requirements:

  • Effective experience in CMC Regulatory Affairs
  • Background in pharmaceutical industry

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Spain

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Mantell Associates
Mantell Associates

Current Openings: 0

Mantell Associates is an industry backed, multidiscipline global Life Science and Pharmaceutical headhunting firm focused on providing staffing solutions, in particular to the Biotech, Pharmaceutical, Large Molecule, Cell & Gene Therapy, CRO & Clinical Operations, Small Molecule, and Life Science Consulting sectors with its headquarters based in the City of London, and offices in Miami and Zug. With success ranging across C-Suite, Commercial and Operational support, we pride ourselves on our ability to bring the top talent on the market to our clients, and the best opportunities to the top talent. Our services span across our Partnership Service, Contingency, Executive Search and Project Management modules meaning that we are able to cater to our clients every need, from Senior Business appointments all the way through to large bulk business projects. At Mantell Associates, we pride ourselves on our long-term partnerships and our ability to assist people and companies to develop and grow.
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