Director, Regulatory Affairs – CMC

Rocket Pharmaceuticals • Cranbury, NJ

20h • $204,000 - $244,000

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

• Experience in biotechnology and/or gene therapy products strongly preferred

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.

Benefits

• Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
• 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 Year’s, 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees