Regulatory Affairs- Manager-CMC

The Manager, Regulatory Affairs – CMC will lead and oversee all Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to ANDAs, supplements, and amendments. The role involves authoring and reviewing CMC sections, evaluating change controls, coordinating cross-functional activities, interacting with regulatory agencies, and providing leadership, training, and guidance to the regulatory affairs team.

Requirements

• Master’s degree in pharmacy, chemistry, pharmaceutical sciences, or related field
• 4-6 years of experience in regulatory affairs focusing on CMC for ANDAs, supplements, and amendments in the pharmaceutical industry
• Strong knowledge of FDA and global regulatory requirements for generics, supplements, and post-approval changes
• Excellent cross-functional collaboration, analytical, and problem-solving skills
• Strong written and verbal communication skills for drafting regulatory documents and interacting with agencies
• Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• 401(k) or other retirement plan
• Paid Time Off
• Life Insurance
• Disability Insurance