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.

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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

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Regulatory Affairs CMC Specialist - Requirements:

• Effective experience in CMC Regulatory Affairs

• Background in pharmaceutical industry drugs

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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.