Regulatory Affairs Manager, CMC

The role

The Manager of Regulatory Affairs, CMC will develop and lead regulatory CMC registration and post-approval strategies for ophthalmic products. This person will lead regulatory affairs activities for the ophthalmic unit and collaborate with various functional areas to lead products through FDA and global regulatory processes.

What you will do

• Lead development of regulatory strategies for successful registration and post-approval commercialization.
• Oversee regulatory matters for 503A and 503B compounded ophthalmic drug formulations.
• Supervise the development of all marketing materials.
• Drive execution of regulatory strategy from pre-IND to launch and product lifecycle management.
• Ensure regulatory compliance for filing requirements for assigned compounds.
• Define and review CMC content requirements for regulatory submissions.
• Build, hire, manage, and develop the Regulatory team.
• Plan and execute activities in support of all regulatory submissions.
• Serve as the primary company contact with the US FDA.
• Provide regulatory guidance to company personnel across all stages of product development.

Required qualifications

• BS/BA degree in a scientific discipline
• 6+ years of pharmaceutical regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
• Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
• Ability to provide regulatory advice and make reasoned decisions on issues without clear guidance
• Leadership, problem-solving ability, attention to detail, and flexibility
• Ability to exercise good judgment in elevating and communicating issues to line management
• Excellent written and oral communication skills

Nice to have

• Advanced degree
• Active participation in Agency/Industry groups/forums

About the company

Harrow is a leading provider of ophthalmic disease management solutions in North America. It is an entrepreneurial company with a comprehensive ophthalmic pharmaceutical portfolio.