Director, Regulatory Affairs-Global Regulatory Lead

Location of role Gaithersburg, MD, Radnor, PA, Oxford, UK Department Regulatory Affair s Key Responsibilitie s 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 to include: Regulatory scientific and tactical strategy development, IND development/submission /maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. The role will also involve interacting with our global sites, both in-house and outsourced. Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, MHRA, and other local Health Authorities providing an excellent opportunity to develop worldwide regulatory experience. The ideal candidate will have experience gained in biologics and the preparation of late-stage regulatory fillings, with regulatory tactical leadership skills and implementation. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment and is able to lead the regulatory strategy through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role. KEY 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. SUPERVISORY RESPONSIBILITY This position does not initially have direct reports but may in the future. COMPETENCIES 2. Time Management. 4. Personal Effectiveness/Credibility. 5. Flexibility. 6. Technical Capacity. 7. 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 & KNOWELEDGE 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. 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. #J-18808-Ljbffr