Associate Director, Regulatory Scientific Affairs

4 days ago


Waltham, Massachusetts, United States Alkermes Full time

Job Summary

Alkermes is seeking a highly skilled Associate Director to lead our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory strategies and guidance on post-approval CMC topics.

Key Responsibilities

  • Develop and lead regulatory CMC strategies focused on external product life-cycle improvements
  • Collaborate with cross-functional teams and external partners to ensure compliance with regulatory requirements
  • Represent Regulatory Affairs on cross-functional committees, project teams, and vendor/contractor meetings
  • 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
  • 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

  • Deep understanding of global regulatory standards (FDA, EMA, TGA, Health Canada, ICH, WHO)
  • Expertise in regulatory CMC areas, including FDA requirements for INDs, NDAs, DMFs, and sNDAs
  • Ability to interpret and resolve issues within the framework of SOPs, CFRs, regulatory guidelines, and cGMPs
  • Strong writing skills, with attention to producing high-quality regulatory documents
  • Ability to adapt to shifting priorities and influence regulatory decisions
  • Commitment to continuous improvement, identifying risks, and escalating issues to Regulatory management and/or key stakeholders, as necessary
  • Bachelor's degree in a scientific discipline required; post-graduate degree preferred
  • Relevant regulatory experience in post-approval CMC changes is required

About Alkermes

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. As a fully-integrated, global biopharmaceutical company, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.



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