Director, Regulatory Affairs

Role Summary

The Director of Regulatory Affairs leads regulatory strategy and submissions for Immunocore's development programs, coordinating global activities across US and international authorities. This role provides regulatory leadership on IND/CTA, BLA/sBLA submissions, labeling, and regulatory intelligence, interacting with in-house and external sites and establishing relationships with the FDA and other local Health Authorities. The ideal candidate will have biologics regulatory expertise, leadership in late-stage regulatory filings, and the ability to deliver under pressure in an innovative, agile environment. Location: Gaithersburg, MD; Radnor, PA.

Responsibilities

• Provide regulatory leadership and support to cross-functional development project teams to jointly achieve strategic objectives.
• Be responsible for the US and ex-US regulatory activities associated with the project teams.
• Develop regulatory scientific and tactical strategic plans, and target labeling to support product development.
• Provide leadership for 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 the documentation supporting regulatory submissions to the US and wider international regulatory authorities, in support of CTA/INDs, BLAs/MAAs, CTA safety reports and updates, along with all other regulatory submissions.
• Be the center of excellence (point of contact) of all regulatory requirements and guidelines globally, in particular within the US, and monitor the regulatory environment for oncology, antifectives, 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.
• Overseeing 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, with strong problem solving and knowledge of regulatory strategies and compliance with all regulations and guidance.
• Review and ensure the quality of detailed scientific and technical information is presented clearly and supported by robust data.
• This position does not initially have direct reports but may in the future.

Qualifications

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

Skills

• Communication Proficiency
• Time Management
• Collaboration Skills
• Personal Effectiveness/Credibility
• Flexibility
• Technical Capacity
• Stress Management/Composure

Education

• Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 5-10 years’ experience or BS with 8-12 years’ experience.

Additional Requirements

• Work authorization: Authorization to work in United States.
• Travel: Limited overnight travel; occasional local day travel.
• Physical demands: This is largely a sedentary role; however, some filing is required.