Regulatory Affairs Manager
Posted Updated
Description
About the Role:
A global healthcare consulting firm is seeking their first CMC Regulatory Affairs expert to prepare and review CMC dossiers and advise clients on pharmaceutical development. This role involves leading projects, managing client relationships, and ensuring compliance with global regulatory standards.
Key Responsibilities:
Prepare and review Module 3 CMC documents, IMPDs, and variation dossiers.
Develop regulatory strategies and conduct gap analyses.
Advise on formulation, validation, and stability plans.
Lead projects and act as primary client contact for CMC matters.
Provide training and support to colleagues and clients.
Requirements
Qualifications:
8+ years in CMC regulatory affairs or related roles.
Strong knowledge of global CMC regulations and project management.
Excellent communication and leadership skills.
Degree in pharmacy, pharmaceutical sciences, chemistry, or related field preferred.