Regulatory Affairs CMC Specialist - Pharmaceutical

Posted 29 February 2024
Salary Negotiable
Job type Full Time
Discipline Clinical & Data
Contact NameGeorge Hebden Lee

Job description

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 drugs

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.