Mantell Associates is currently partnered with a leading organisation on their search for a specialist to join their Regulatory team. They are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs).

RA CMC Specialist Responsibilities:

• Contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities

• Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation

• Reviews data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them

• Writes/assembles CMC sections of regulatory submissions

• Develop and maintain project plans and schedules for CMC submissions

• Ensures all CMC dossiers are stored in the company database

• Provide guidance minimally on ICH, FDA and EU CMC guidelines

• 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

RA CMC Specialist Skills & Qualifications:

• Effective experience in CMC Regulatory Affairs

• Background in pharmaceutical industry

• Experience with topical and/or systemic drugs (Biologics and/or Small Molecules)

• Bachelor's Degree in Science discipline

• Previous experience of dealing with regulatory agencies and FDA is a must

• Ability to work on problems of diverse scope

• Identifies priorities and key issues in complex situations and solves with minimal assistance

• Exercises judgement within generally defined regulatory practices and policies

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