The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.

Responsibilities:

• Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
• Serve as primary RA contact on project teams to support product development.
• Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
• Respond to FDA queries and deficiencies.
• Provide guidance to RA Associates and aid in development of team.
• Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
• Monitor and interpret new and evolving regulations and assess impact on company products.
• Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
• Oversee adverse event reporting process and ensure compliance with reporting requirements.
• Support due diligence activities, licensing, and partnerships.

• Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
• 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
• Highly detail-oriented and possess considerable problem-solving and organization skills
• Ability to work on complex projects and take initiative with general direction and minimal guidance
• Ability to be flexible with a change in priorities
• Excellent written, verbal, and listening skills, must work well with others
• Experience using an electronic document control system
• Experience with eCTD publishing software preferred
• Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat