Regulatory CMC Manager Salary in Maine

The Regulatory CMC Manager is responsible for leading and managing the Chemistry, Manufacturing, and Controls (CMC) regulatory activities for pharmaceutical products. This includes developing and implementing regulatory strategies, preparing and submitting CMC sections of regulatory submissions, and ensuring compliance with global regulatory requirements. The Regulatory CMC Manager also collaborates with cross-functional teams to provide regulatory guidance on CMC-related issues, assess the impact of regulatory changes on product development, and communicate with regulatory agencies as needed. Additionally, they may oversee CMC regulatory submissions for new product registrations, variations, and renewals, and provide support for regulatory inspections and audits. Overall, the Regulatory CMC Manager plays a critical role in ensuring the successful regulatory approval and commercialization of pharmaceutical products.