Regulatory Affairs Director for CMC Operations

4 days ago


Waltham, Massachusetts, United States Alkermes Full time
Job Description Overview: Alkermes is a global biopharmaceutical company dedicated to developing innovative treatments for complex and difficult-to-treat psychiatric and neurological disorders. We are seeking an experienced Associate Director of CMC Regulatory Affairs to join our team in Waltham, MA.

Key Responsibilities:
  • Develop and lead regulatory CMC strategies for post-approval changes, ensuring compliance with global regulatory requirements.
  • Represent Regulatory Affairs on cross-functional committees, project teams, and vendor/contractor meetings.
  • Collaborate with Quality, External Operations, and Manufacturing teams to ensure regulatory compliance.
  • Lead the preparation, review, and submission of regulatory CMC documentation and dossiers.
  • Review and approve change controls, assessing regulatory impacts of product and process changes.
  • Coordinate responses to CMC-related queries from Health Authorities.
  • Offer regulatory and scientific expertise in writing and reviewing applications to ensure compliance and successful filings.
  • Manage regulatory relationships with external CMOs and third-party packaging suppliers, assessing regulatory impact of proposed changes.
  • Develop Health Authority meeting materials.
  • Drive initiatives to enhance regulatory standards and practices within the organization.
  • Monitor regulatory changes and communicate their impact to internal teams.
Requirements:
  • Bachelor's degree in a scientific discipline required; post-graduate degree preferred.
  • Relevant regulatory experience in post-approval CMC changes is required.
About Us: Alkermes is committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. We strive to foster a culture of diversity, inclusion, and belonging throughout our business, recognizing that our diversity of thought, background, and perspective makes us stronger.

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