Executive Director/AVP Regulatory Affairs CMC

I'm thrilled to be partnered with a multi-award-winning Biotech that's making waves with its innovative pipeline targeting a wide arrary of rare diseases. With five dynamic trials currently underway, they’re looking for a Regulatory expert ready to take on a pivotal role helping to expand the team and drive these groundbreaking studies through to submission. This is an incredible opportunity to make a real impact in a rapidly growing field reporting into the CDO!

As the AVP Regulatory CMC you will lead the Regulatory CMC team. This strategic role ensures that CMC submissions comply with FDA, EMA, and global regulatory standards, aligning them with business objectives. The position is crucial for navigating regulatory requirements with agencies, supporting cross-functional teams, and addressing CMC-related challenges.

Responsibilities:

• Develop and implement CMC regulatory strategies, guiding teams in compliance across product lifecycle stages.
• Manage preparation, review, and submission of CMC sections for regulatory filings, including INDs, NDAs, BLAs, and MAAs.
• Lead CMC documentation processes, ensuring accuracy, data integrity, and adherence to regulatory expectations.
• Partner with R&D, manufacturing, and quality teams to integrate regulatory considerations into development and production processes.
• Assess and mitigate regulatory risks; address compliance issues with actionable strategies.
• Act as Rocket’s CMC representative to regulatory bodies, staying informed on industry trends to enhance regulatory practices.

Qualifications:

• Advanced degree in relevant field(M.S., Ph.D., PharmD) is preferred.
• At least 10 years of regulatory affairs experience, specifically in CMC, with proven experience in managing CMC submissions.
• Experience in Biologics rare disease desired. Experience in Gene Therapy preferred.
• Expertise in FDA, EMA, and international CMC regulatory requirements, as well as strong leadership skills to manage high-performing teams.
• Strong communication skills, with an ability to manage multiple priorities in a dynamic setting.

Apply today or get in touch directly -