Director, Regulatory Affairs – CMC

Position Summary

Rocket Pharma is seeking a Director, Regulatory Affairs – CMC to support the success of our gene therapy programs. This role serves as the global product leader for CMC regulatory strategy.

Responsibilities

• Work collaboratively to develop and execute Regulatory-CMC strategies for gene therapy products.
• Develop, propose, and implement global CMC regulatory strategies for gene therapy products from early development to licensure.
• Lead the preparation and review of CMC submission documents, registration dossiers, and responses to health authorities.
• Serve as the CMC Regulatory lead in Health Authority interactions and meetings.
• Work with cross-functional CMC, analytical, quality, and regulatory teams to create high-quality submission materials.
• Represent CMC regulatory strategy at cross-functional Global Project Team, Change Management team, and relevant governance meetings.
• Ensure that CMC submissions are complete, accurate, and meet all regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
• Drive regulatory CMC strategy for product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks.
• Advise on policy changes and engage externally if necessary.
• Oversee the development and implementation of internal policies and procedures to ensure compliance with regulatory requirements and industry best practices.
• Identify and assess potential regulatory risks related to CMC and develop strategies to mitigate these risks across Rocket’s pipelines.

Qualifications

• Minimum BS Degree; advanced degree preferred (PharmD/Ph.D., or equivalent) in a relevant scientific discipline.
• 12 years of Regulatory Affairs experience required (minimum of 8 years with an advanced degree), preferably within the pharmaceutical industry.
• Experience in gene therapy products strongly preferred.
• At least 8 years of CMC regulatory strategy experience required.
• Experience in interfacing and responding to relevant global regulatory authorities, especially with respect to gene therapy products.
• Knowledge and understanding of US, EU, and international regulations and ICH guidelines related to CMC gene therapy development.
• Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages.
• Thrives in a fast-paced environment combining strategic and tactical capabilities.
• Excellent written and verbal communication skills, analytic, and problem-solving abilities.

Pay

The expected salary range for this position is $204,000 to $244,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position, and availability of similar talent in a competitive market.