Associate Director/Director of Regulatory Affairs

19 hours ago

Cambridge, MA, United States Cedent Full time
Summary:
Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing regulatory strategies from early development through late-stage clinical programs. The role involves direct interaction with the FDA and global regulatory agencies, leading submissions, and providing regulatory guidance across functional teams.

Key Responsibilities:
  • Serve as the primary contact with FDA and other regulatory agencies, preparing for and leading agency meetings.
  • Lead the preparation and submission of domestic and global regulatory documents (e.g., IND, CTA, NDA/MAA) and manage response strategies to regulatory inquiries.
  • Prepare and maintain regulatory submissions, ensuring compliance with FDA and global health authority requirements.
  • Provide interpretation, guidance, and training on global regulations to internal teams, identifying regulatory opportunities and risks.
  • Pursue special and expedited review designations as appropriate for development programs.
Qualifications:
  • Bachelor's degree in a relevant field; advanced degree preferred.
  • 10+ years of experience in the pharmaceutical/biotechnology industry, with at least 5 years in Regulatory Affairs.
  • Experience in key areas of regulatory affairs, including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus.
  • Experience in ophthalmology is an advantage.
  • Project management experience is beneficial.
  • Strong oral and written communication skills.
  • Comprehensive understanding of global pharmaceutical development, including clinical and nonclinical activities.

Department: Direct Clients
This is a full time position

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