Director, Regulatory Affairs-Global Regulatory Lead
Immunocore
9 days ago
Remote friendly (Gaithersburg, MD)
United States
Corporate Functions
Responsibilities:
- Provide regulatory leadership for assigned development projects; develop regulatory scientific/tactical strategy, regulatory intelligence, and agency liaison.
- Lead US and ex-US regulatory activities with global in-house/outsourced sites.
- Establish and maintain relationships with FDA; oversee submissions to EMA, MHRA, and other Health Authorities.
- Develop regulatory plans and target labeling to support product development.
- Lead creation and writing of regulatory submission documents (briefing documents; IND/CTA supporting documents; labeling; CTD/BLA/MAA for eCTD submissions).
- Manage and coordinate preparation and submission of regulatory documentation (CTA/INDs, BLAs/MMAs, CTA safety reports/updates, and other filings).
- Serve as global center of excellence for regulatory requirements/guidelines; monitor regulatory environment for oncology, antifectives, autoimmune diseases, and biologics.
- Contribute to procedures/work practices for late-stage development and commercialization.
- Oversee regulatory review of clinical trial labeling and CMC submissions (with Director of Regulatory CMC).
- Ensure quality and clarity of scientific/technical information and evidence for conclusions.
Qualifications (Essential):
- Solid drug development leadership track record in dynamic teams.
- Strong scientific background; emerging ability to develop regulatory scientific strategies.
- Strong global regulatory knowledge; excellent US regulatory expertise with submission experience.
- Experience supporting global clinical studies.
- Experience managing/preparing/submitting INDs/CTAs, BLAs/NDAs, MAAs; at least 1 NME BLA/NDA highly desirable.
- Experience preparing for and conducting Health Authority Meetings (FDA required); maintain ongoing liaison.
- Agile mindset; proven leadership, communication, and interpersonal skills.
- Advanced degree preferred (M.S./PharmD/Ph.D./M.D.) with 5–10 years’ experience, or BS with 8–12 years’ experience.
Position: Full-time, exempt; occasional overtime; limited overnight and occasional local day travel.
- Provide regulatory leadership for assigned development projects; develop regulatory scientific/tactical strategy, regulatory intelligence, and agency liaison.
- Lead US and ex-US regulatory activities with global in-house/outsourced sites.
- Establish and maintain relationships with FDA; oversee submissions to EMA, MHRA, and other Health Authorities.
- Develop regulatory plans and target labeling to support product development.
- Lead creation and writing of regulatory submission documents (briefing documents; IND/CTA supporting documents; labeling; CTD/BLA/MAA for eCTD submissions).
- Manage and coordinate preparation and submission of regulatory documentation (CTA/INDs, BLAs/MMAs, CTA safety reports/updates, and other filings).
- Serve as global center of excellence for regulatory requirements/guidelines; monitor regulatory environment for oncology, antifectives, autoimmune diseases, and biologics.
- Contribute to procedures/work practices for late-stage development and commercialization.
- Oversee regulatory review of clinical trial labeling and CMC submissions (with Director of Regulatory CMC).
- Ensure quality and clarity of scientific/technical information and evidence for conclusions.
Qualifications (Essential):
- Solid drug development leadership track record in dynamic teams.
- Strong scientific background; emerging ability to develop regulatory scientific strategies.
- Strong global regulatory knowledge; excellent US regulatory expertise with submission experience.
- Experience supporting global clinical studies.
- Experience managing/preparing/submitting INDs/CTAs, BLAs/NDAs, MAAs; at least 1 NME BLA/NDA highly desirable.
- Experience preparing for and conducting Health Authority Meetings (FDA required); maintain ongoing liaison.
- Agile mindset; proven leadership, communication, and interpersonal skills.
- Advanced degree preferred (M.S./PharmD/Ph.D./M.D.) with 5–10 years’ experience, or BS with 8–12 years’ experience.
Position: Full-time, exempt; occasional overtime; limited overnight and occasional local day travel.