Associate Director, Regulatory Science

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

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)

Job Summary

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.

Key Responsibilities

• 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

Actively participate in regulatory compliance and regulatory team development

• 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

Required Knowledge/Experience

• 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

Education / Key Competencies

• 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 and with other functions and stakeholders
• Ability to handle multiple tasks in parallel in a fast‑paced environment; ability to plan, prioritize and respond effectively to program/activities changes
• Ability to develop partnerships that support a strong cross‑functional and inclusive team environment
• Ability to work in autonomy on allocated program(s)
• Excellent organizational, computer and documentation skills
• Solution‑oriented approach to problem‑solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction
• General interest in a broad range of Regulatory activities
• Strong interpersonal skills including verbal and written communication

Salary Range

The anticipated salary for this position is $190,000 - $240,000, plus a comprehensive benefits and incentive package. Actual salary may vary based on experience, qualifications, and location.

Our client is an equal opportunity employer.