Senior Director, Regulatory Affairs

Key Responsibilities

• Provide regulatory leadership and support to cross-functional development project teams to jointly achieve strategic objectives.
• Responsible for US regulatory activities associated with project teams.
• Develop regulatory scientific and tactical strategies and target labeling to support product development.
• Lead the development and writing of regulatory submission documents, including briefing documents, IND/CTA supporting documents, labeling, and CTD/BLA/MAA documentation for eCTD-compliant submissions.
• Manage, prepare, coordinate, and be responsible for the submission of documentation supporting regulatory submissions to US and international regulatory authorities, including CTA/INDs, BLAs/MAAs, CTA safety reports and updates, and other regulatory submissions.
• Serve as the center of excellence (point of contact) for all regulatory requirements and guidelines globally, particularly within the US, and monitor the regulatory environment for oncology, anti-infectives, autoimmune diseases, and biologics.
• Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in late-stage development and commercialization.
• Oversee regulatory review of clinical trial labeling and CMC submissions for regulatory compliance, in conjunction with the Director of Regulatory CMC.
• Demonstrate a high level of professionalism, efficiency, and leadership within the team while demonstrating critical thinking, effective problem-solving, and strong knowledge of regulatory strategies and alignment with compliance requirements.
• Responsible for reviewing and ensuring the quality of detailed scientific and technical information is presented clearly and that supporting conclusions are adequately evidenced by data.
• Review and provide input, guidance, and approval for tactical and administrative plans for junior-level global regulatory leads to ensure consistency of implementation across the organization, including both direct and dotted-line reports.
• Provide input and guidance for scientific regulatory strategies for direct reports and discuss with the Head of Regulatory Sciences prior to governance meetings to ensure alignment.
• Present proposed scientific and tactical regulatory strategies at Immunocore governance meetings and incorporate feedback to achieve full alignment.
• Provide regulatory leadership for the implementation of plans within project teams, including leadership for all health authority interactions globally.
• As the organization grows, oversee, guide, and mentor direct reports for their assigned projects, either supporting the same project or another assigned project.
• Provide preliminary review of direct reports’ regulatory scientific strategies and discuss with the Head of Regulatory Sciences to gain alignment prior to governance meeting review(s).

Supervisory Responsibility

• May include line manager responsibilities for direct reports and dotted-line reporting.
• Leads review and approval of tactical and administrative regulatory plans to ensure global consistency for both direct and dotted-line reports.
• Provides guidance to direct reports for scientific regulatory strategies and gains alignment with the Head of Regulatory Sciences.
• Promotes communication and cooperation among functions to foster a unified organizational spirit.

Experience & Knowledge

• Solid track record in drug development and leadership within dynamic project teams.
• Strong scientific background with evidence of ability to develop regulatory scientific strategies.
• Strong understanding of global regulatory requirements to form tactical regulatory strategies.
• Excellent knowledge of US regulatory requirements and extensive experience with submissions in drug development.
• Global experience desirable.
• Experience working cross-functionally and globally within Regulatory Affairs.
• Experience supporting global clinical studies.
• Experience managing, preparing, and submitting INDs/CTAs, BLAs/NDAs, and MAAs.
• Submission of at least 1 NME BLA/NDA is highly desirable.
• Experience preparing and conducting Health Authority Meetings (FDA required).
• Ability to develop and maintain ongoing liaison relationships with FDA and other global Health Authorities.
• Demonstrated ability to be agile and accommodate changing priorities.
• Proven leadership, excellent communication, and interpersonal skills.

Education & Qualifications

Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 8–12 years of experience, or BS with 10–15 years of experience.

Pay

US Salary Range: $250,000 – $270,000