Sr Director Regulatory GRL

Senior Director, Global Regulatory Lead 
 

Our client is growing, rare genetic disease company based in the Princeton area, dedicated to developing treatments across hematology, cardiology, and other undisclosed diseases. With a pipeline of multiple late-stage programs and BLAs slated for the coming year, this is an exciting time to join a company led by industry leaders with deep expertise and a shared sense of purpose. This role is at the cutting edge of innovation, offering the opportunity to provide global regulatory leadership for the development, registration, and life-cycle management of groundbreaking rare disease programs. The Senior Director will also oversee and mentor a growing regulatory team.

Key Responsibilities:

• Provide global regulatory leadership for the development, registration, and life-cycle management of our client's LV gene therapy products.
• Develop regulatory strategies for products to support development, licensure, and commercialization, including leading of BLA filing activities.
• Represent regulatory at global product team meetings.
• Guide, coach, and manage a team of regulatory professionals to ensure their professional development and advancement.
• Provide 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.
• Ensure the successful implementation and execution of regulatory plans to support product approval and commercialization.
• Stay current with US, EU, and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs.
• Lead interactions with US FDA, EMA, MHRA, and other regulatory agencies as needed for all aspects pertaining to drug development.
• Lead the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
• Serve as a subject matter expert on relevant global regulations, staying abreast of changes in the global regulatory environment.
• Support the development of relevant policies, processes, and SOPs.
• Provide regulatory due diligence assessments of new business opportunities as required.
   

Qualifications:

• MS degree and 12+ years of Pharmaceutical industry experience.
• 7+ years of regulatory filing (BLA/MAA) strategy preferred.
• Strong expertise in hematology for advanced biologics, particularly those with multidisciplinary experience and a PharmD or PhD, is highly encouraged to apply.
• Rare disease experience is desirable.
• Extensive hands-on regulatory experience, including managing IND/CTA, NDA/BLA/MAA submissions, lifecycle management.
• 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 complex issues.
• 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.