Associate Director/Director of Regulatory Affairs (Cambridge, MA)

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.

• 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.
  

• 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