Director, Regulatory Affairs - AAV

Rocket Pharmaceuticals • Cranbury Township, NJ

389d

About The Position

The Director of Regulatory Affairs at Rocket Pharma will lead US regulatory efforts for innovative gene therapy programs, focusing on the development, registration, and life-cycle management of products aimed at treating rare diseases. This role requires strategic planning, regulatory document preparation, and fostering relationships with the FDA to ensure compliance and expedite approvals. The position is integral to the company's mission of advancing gene therapies and requires a hands-on approach in a dynamic work environment.

Requirements

• MS, PharmD/PhD Degree preferred.
• 10+ years of experience in the pharmaceutical industry.
• 5+ years of regulatory filing strategy experience (IND/CTA/BLA/MAA) preferred.
• Strong expertise in AAV gene therapy and IND submission experience.
• Hands-on regulatory experience in submission of INDs.
• Extensive experience interacting with Health Authorities.
• Ability to develop and implement US regulatory strategies.
• Desirable experience in rare diseases and/or gene therapy.
• Strong scientific foundation with understanding of preclinical and gene therapy products.
• Practical understanding of ICH and FDA guidelines and regulations.
• Excellent verbal and written communication skills.

Nice To Haves

• Experience in rare disease and gene therapy.
• Creative problem-solving skills.
• Ability to prioritize and manage multiple projects.

Responsibilities

• Provides US regulatory leadership in support of the development, registration, and life-cycle management of Rocket's products.
• Develops the US regulatory plan and advises on regulatory requirements for development plans, study designs, and marketing approval.
• Conducts risk assessments and manages critical issues and FDA interactions.
• Writes regulatory documents such as new INDs, briefing book content, and requests for designations and reviews.
• Fosters positive relationships with the FDA and ensures successful implementation of regulatory plans.
• Resolves regulatory issues impacting development programs to meet business goals.
• Builds partnerships with senior stakeholders to share knowledge and resources.
• Liaises and negotiates with the FDA regarding drug development and regulatory pathways.
• Leads the completion of IND/CTA and other global submission documents.
• Serves as a subject matter expert on US regulations and assesses the impact of regulatory changes on product development.
• Proactively manages critical issues and supports the development of relevant policies and SOPs.

Benefits

• Competitive compensation package with generous 401K match and stock options.
• Excellent health benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree