US Regulatory Strategy Lead – Remote

Broadreach Executive Search; Massachusetts; Hybrid; USD 190,000 - 240,000; Full time

Job summary

Broadreach Executive Search presents an opportunity with a global gene therapy leader headquartered in the Greater Boston area to join the Regulatory Science team as Associate Director, Regulatory Science. This role focuses on developing global regulatory strategy and executing regulatory activities for ex-vivo gene therapy assets.

You will partner with Global Regulatory Leads, identify risks, manage FDA submissions (INDs, ODDs, BLA considerations), and coordinate cross‑functional teams to drive

Qualifications

• Significant experience in development and execution of US regulatory strategies for development programs.
• Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus.
• Strong knowledge of US CFR and FDA guidelines.
• Experience with US innovative expedited paths to approval.
• Track record of INDs preparation, management up to FDA clearance and maintenance.
• Experience leading a team for major health authority interactions (e.g., pre-IND meetings).
• Experience in regulatory submission project management.
• Experience in preparation and submission of a BLA is a plus.

Responsibilities

• Provide regulatory inputs to related cross‑functional program teams under the oversight of the Executive Director, Regulatory Science.
• Develop the US regulatory strategy in line with corporate goals.
• Identify regulatory risks, develop mitigation strategies, and support agency engagement plans.
• Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing.
• Execute the US regulatory strategy: liaise with US authorities, plan and review submissions to the FDA (IND, ODD, Fast Track/RMAT designations, Pediatric study plans); prepare meeting requests and coordinate cross‑functional meetings; ensure documents are accurate and compliant.
• Monitor, analyze and disseminate intelligence on US regulatory matters impacting development programs.
• Lead the implementation of new US regulations/guidelines in collaboration with Global Regulatory Leads.
• Contribute to updates and SOP development related to regulatory activities.
• Participate in internal audits and health authority inspections.
• Share expertise within the regulatory team.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Problem solving

Attention to detail

Communication

Education

PharmD or PhD in a scientific discipline

Regulatory Affairs certification

Job description

Broadreach Executive Search presents an opportunity with a global gene therapy leader headquartered in the Greater Boston area to join the Regulatory Science team as Associate Director, Regulatory Science. This role focuses on developing global regulatory strategy and executing regulatory activities for ex-vivo gene therapy assets.

You will partner with Global Regulatory Leads, identify risks, manage FDA submissions (INDs, ODDs, BLA considerations), and coordinate cross‑functional teams to drive