Associate Director, Regulatory Science

Our client, a global gene therapy leader with U.S. headquarters in the Greater Boston area, is focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs).

Title: Associate Director, Regulatory Science

Location: Remote (US)

Reports to: Executive Director, Regulatory Science (US)

This role is a unique opportunity to join the Regulatory Science team, which is responsible for the development of global regulatory strategy and execution of regulatory activities for ex-vivo Gene Therapy assets. This position is ideal for someone with a solid US regulatory background who can develop innovative regulatory strategies and apply strong skills in execution, collaboration, problem-solving, and attention to detail to contribute to groundbreaking science.

• Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross‑functional program teams
• Develop the US regulatory strategy, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)
• Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans
• Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing
• Execute the US regulatory strategy: be the primary liaison with US regulatory authorities for the assigned program(s); plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans; prepare FDA meeting requests, briefing documents, coordinate and prepare cross‑functional teams for meetings, and interface with US regulatory authorities;
  
  coordinate and prepare responses to questions and requests for information from US regulatory authorities; ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines

• Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs
• Lead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
• Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
• Participate in internal audits and future health authority inspections
• Share expertise and learning experiences within the regulatory team

• Significant experience in the development and execution of US regulatory strategies for development programs in industry-related US Regulatory Affairs
• Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus
• Very good knowledge and understanding of US CFR and FDA guidelines is a must — understanding of EMA regulations and guidelines is a plus
• Previous experience in using US innovative expedited paths to approval in the frame of global development is a plus
• Track record of INDs preparation, management up to FDA clearance and maintenance
• Previous experience of leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2 meetings, etc.)
• Experience in regulatory submission project management
• Previous experience in the preparation and submission of a BLA is a plus

• PharmD or PhD in a scientific discipline
• Regulatory Affairs certification is a plus
• Strong attention to detail, translating into the ability to produce high-quality regulatory documents
• Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team…