Responsibilities:

• Provides global regulatory leadership in support of the development, registration, and life-cycle management of Rocket’s products.
• Guides, coaches and manages a team of regulatory professionals to ensure their professional development and advancement.
• Provides strategic regulatory direction and mentorship on programs including developing the overall regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk assessments, and managing critical issues and Health Authority interactions.
• Ensures the successful implementation and execution of regulatory plans to support product approval and commercialization.
• Harnesses knowledge of US, EU and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
• Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
• Liaises and negotiates with US FDA, EMA, MHRA and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatory pathways for the company’s gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
• Takes a hands-on approach in leading the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
• Serves as a subject matter expert on relevant global regulations, stays abreast of changes in the global regulatory environment, and assesses impact of changes on business and product development programs.
• Proactively manages critical issues, taking leadership for regulatory contribution.
• Supports the development of relevant policies, processes, and SOPs.
• Provides regulatory due diligence assessments of new business opportunities as required.

Requirements:

• MS, PharmD/PhD Degree preferred
• MS degree and 10+ years Pharmaceutical industry experience.
• 5+ years of regulatory filing (BLA/MAA) strategy preferred.
• We encourage applicants with strong expertise in CART or LVV, particularly those with multidisciplinary experience and a PharmD or PhD, to apply. This skill set and educational background may outweigh the requirement for a specific number of years of experience.
• Extensive hands-on regulatory experience, including managing IND/CTA, NDA/BLA/MAA submissions, lifecycle management, and
• Extensive experience in interacting with Health Authorities.
• Ability to develop and implement complex global regulatory strategies.
• Strong scientific foundation, including a strong understanding of gene therapy products and development.
• Practical understanding, interpretation, and application of relevant ICH, FDA and EMA guidelines and regulations.
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
• Ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Sense of urgency and perseverance to achieve bringing curative therapies to patients.
• Rare disease and/or gene therapy experience is desirable.