Position Summary

Rocket Pharma is seeking a Director, Regulatory Affairs 6 CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy. Reporting to the Associate Vice President, Regulatory Affairs, they will proactively manage multiple Regulatory CMC projects by coordinating with both internal and external stakeholders. They will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.

• Work collaboratively with a focus on development and execution of Regulatory-CMC strategies for gene therapy products.
• Develop, propose, and execute a global Regulatory-CMC strategy for a Rocket9s gene therapy products from early development to licensure.
• Lead the preparation and review of CMC submission documents, registration dossiers, and responses to health authorities with other relevant functions. Submissions include health authority briefing packages/IND/IMPD/BLA and MAA regulatory filings
• 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.
• 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 whether/when to engage externally in such discussions
• 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 Rocket9s pipelines.

• 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 biotechnology and/or 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.
• Thrive in a fast 6paced environment combining strategic and tactical capabilities.
• Excellent written and verbal communication skills, analytic and problem-solving.

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 employee9s experience, location of the position and availability of similar talent in a competitive market.

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year9s, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).