Director, Regulatory Affairs-Global Regulatory Lead in Oxford

Location of role: Radnor, PA, Gaithersburg, MD, Oxford, UK

Department: Regulatory Affairs

Key Responsibilities

• The Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs.
• Regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence.
• Interacting with our global sites, both in-house and outsourced.
• Establishing a successful relationship with the FDA, along with overseeing submissions to the EMA, MHRA, and other local Health Authorities.
• Providing regulatory leadership and support to cross-functional development project teams to jointly achieve strategic objectives.
• Developing regulatory scientific and tactical strategic plans, and target labelling to support product development.
• Providing leadership for the development and writing of regulatory submission documents, including Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.
• Managing, preparing, co-ordinating and being responsible for the submission of the documentation supporting regulatory submissions to the US and wider international regulatory authorities.
• Being the center of excellence (point of contact) of all regulatory requirements and guidelines globally, particularly within the US.
• Contributing 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 labelling and CMC submissions for regulatory compliance.
• Demonstrating a high level of professionalism, efficiency, and leadership within the team.
• Reviewing and ensuring the quality of detailed scientific and technical information is presented clearly and supporting conclusions are adequately evidenced by the data.

Supervisory Responsibility

This position does not initially have direct reports but may in the future.

Competencies

• Time Management
• Personal Effectiveness/Credibility
• Flexibility
• Technical Capacity
• Stress Management/Composure

Immunocore Values

• We lead with science to benefit patients
• We are entrepreneurial
• We value diversity to drive innovation
• We respect each other and act with integrity
• We do the right thing

Person Specification

Experience & Knowledge

• Solid track record in drug development and leadership within dynamic project teams.
• Solid scientific background with evidence of emerging ability to develop regulatory scientific strategies.
• Strong understanding of global regulatory requirements to form functional regulatory strategies.
• 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.
• Experience in supporting global clinical studies.
• Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs.
• Submission of at least 1 NME BLA/NDA is highly desirable.
• 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.
• Demonstrate ability to be agile to accommodate changing priorities.
• Must have proven leadership, excellent communication and interpersonal skills.

Preferred Experience & Knowledge

• Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs.
• Submission of at least 1 NME BLA/NDA is highly desirable.
• 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.

Education & Qualifications

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

Position Type & Expected Hours of Work / Travel

This is a Full Time, Exempt position: Occasional overtime may be required based on work priorities, outside of general office hours. Limited overnight travel is expected for this position. There may be occasional local day travel.

US Salary Range: $157,500- $262,500

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease.

Immunocore is proud to be an equal opportunity employer. We are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered.