Immunocore · 1 day ago
Director, Regulatory Affairs
Radnor, PA
Full-time
Onsite
Lead/Staff, Director/Executive
$190K/yr - $237K/yr
5+ years expImmunocore is a pioneering biotechnology company focused on developing transformative medicines for oncology, infectious diseases, and autoimmune diseases. The Director of Regulatory Affairs will provide regulatory expertise for development programs, manage submissions to health authorities, and lead strategic regulatory initiatives. This high-profile role requires strong leadership skills and the ability to work collaboratively in a dynamic environment.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
To provide regulatory leadership and support to cross functional development project teams to jointly achieve strategic objectives
To be responsible for the US and ex-US regulatory activities associated with the project teams
Develop regulatory scientific, and tactical strategic plans, and target labelling to support product development of products
Provide 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
You will manage, prepare, co-ordinate 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/MMAs, CTA safety reports and updates, along with all other regulatory submissions
To be the center of excellence (point of contact) of all regulatory requirements and guidelines globally, in particular within the US, and monitoring the regulatory environment for oncology, antifectives, autoimmune diesases, 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 labelling and CMC submissions for regulatory compliance, in conjunction with the Director of Regulatory CMC
Will need to demonstrate a high level of professionalism, efficiency, and leaderships within the team whilst demonstrating critical thinking, effective problem solving and a strong knowledge of regulatory strategies and compliant with all regulations and guidance
To be responsible for reviewing and ensuring the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data
Qualification
Required
Solid track record in drug development and leadership within a dynamic project team(s)
Solid scientific background with evidence of emerging ability to develop regulatory scientific strategies
Strong understanding of global regulatory requirements to be able 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
Authorization to work in United States
Preferred
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
Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with 5-10 years' experience or BS with 8-12 years' experience
Company
Immunocore
Immunocore is a biotechnology company that specializes in the development of TCR bispecific immunotherapies.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
BlackRockOxford Finance LLCGeneral Atlantic
2024-01-30Post Ipo Debt· $350M
2022-07-18Post Ipo Equity· $140M
2021-02-04IPO
Leadership Team
Bahija Jallal
Chief Executive Officer
Tina St. Leger
Chief Human Resources Officer
Recent News
2025-11-29
Company data provided by crunchbase