Senior Regulatory Associate (Raleigh)

Invenia Group has partnered with a fast-growing BioPharma company, looking to hire a Senior Associate, Regulatory to play a critical role in ensuring compliance with global regulatory requirements and helping to bring life-changing therapies to market efficiently and responsibly.

The Senior Associate, Regulatory supports the development, preparation, and submission of regulatory documents to the U.S. Food and Drug Administration (FDA) and other health authorities. This role ensures the timely submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), amendments, supplements, and annual reports. The Senior Associate, Regulatory also assists in maintaining regulatory compliance and supports cross-functional collaboration across departments.

Role responsibilities :

• Prepare, compile, and submit regulatory submissions such as ANDAs, NDAs, BLAs, INDs / Bio-INDs, and ANADAs in FDA recommended format; perform technical evaluations to ensure completeness and compliance with FDA regulatory standards.
• Support lifecycle management activities for approved products, including submission of post-approval changes, labeling updates, and compliance monitoring & tracking regulatory commitments.
• Monitor and track regulatory submission statuses of pending submissions and coordinate internal teams to ensure timely and accurate responses to regulatory authority queries.
• Coordinate internal review and approval of regulatory documents and submissions.
• Collaborate with cross-functional teams (R&D, Quality, Legal, and Supply Chain) to gather data for submissions.
• Stay current with FDA regulatory guidelines and industry best practices; support the interpretation and dissemination of new regulations and guidance.
• Contribute to the continuous improvement of regulatory processes and templates.

What are we looking for?