Director, Regulatory Affairs – CMC

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

 

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

Rocket Pharma is seeking a Director, Regulatory Affairs – 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.

Responsibilities

• 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 Rocket’s 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 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 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‐paced environment combining strategic and tactical capabilities.
• Excellent written and verbal communication skills, analytic and problem-solving.

 

Compensation

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.

 

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire o