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Location of role Gaithersburg, MD, Conshohocken, PA or Oxford, UK
Department Regulatory Affairs
Key Responsibilities Reporting to the Senior Vice President of Regulatory Sciences, this role leads a team responsible for scientific and tactical regulatory strategy, submissions, approvals, and compliance throughout drug development. Oversight of the Regulatory/Medical Writing Group is also required to ensure consistent, efficient, and timely document development.
The ideal candidate will have experience in biologics drug development, including scientific and tactical regulatory strategy, and late-stage regulatory filings (e.g., NME BLA/NDA, sBLA/sNDA submissions). They must thrive in an innovative, agile, and entrepreneurial environment, effectively collaborate, and perform well under pressure. This high-profile, in-office role is based in Gaithersburg, MD, Conshohocken, PA or Oxford, UK.
Key Responsibilities:
- Collaborate with Senior VP Regulatory Sciences to develop and execute global regulatory strategies with Global Regulatory Leads for all products.
- Ensure consistent representation of the portfolio and Immunocore.
- Collaborate with cross-functional teams (discovery, preclinical, clinical, medical, quality, and commercial) to align regulatory goals with business objectives.
- When required, oversee and/or lead interactions with regulatory agencies (FDA, EMA, etc.) to ensure timely development and approvals.
- Oversee preparation and submission of regulatory documents (INDs/CTAs, BLAs/MAAs, etc.) to ensure aligned with overall strategy across the portfolio for consistency in representing the science and corporation in content and quality.
- Monitor changes in regulations and assess their impact on product development.
- Provide strategic guidance on labelling, risk management, and post-marketing requirements.
- Manage relationships with external partners, consultants, and CROs.
- Oversee Regulatory/Medical Writing Group to ensure development and ongoing training to improve abilities.
- Translate tactics into operational objectives globally.
- Ensure that the organization follows through to accomplish high-quality implementation of plans.
- Streamline processes for timely global labelling changes with internal teams and commercial partners. Contribute to establishing and developing global procedures and practices for consistent and efficient regulatory development, implementation, and operations. Other duties may be assigned.
Supervisory Responsibility:
Global regulatory leads, head of regulatory operations, tactical implementation team, and lead of Regulatory/Medical Writing will report to this role.
Education, Experience and Knowledge:
- Proven track record in all stages of drug development and commercialization.
- Experience in scientific regulatory strategy development required.
- Desired regulatory experience in oncology, anti-infectives, or autoimmune disease.
- Excellent verbal and written communication skills.
- Experience managing, preparing, submitting documents for at least one NME original BLA/NDA, from approval to launch and maintenance (Global NME submission preferred, especially with an EU MAA).
- Multiple sBLA/sNDA submissions for both clinical, labelling and/or CMC.
- Experience preparing for and conducting Health Authority Meetings with FDA/EMA/MHRA/local authorities. Strong analytical capabilities.
- Established credibility and respect with regulatory peers and authorities. Strong understanding of global regulatory requirements for functional regulatory strategies.
- Ability to adapt to changing priorities .
- Proven leadership, communication and interpersonal skills.
- Limited overnight travel; occasional local day travel.
- Authorization to work in United States required.
Education & Experience:
- 15-20+ years’ experience in regulatory affairs in a biopharmaceutical organization.
- Undergraduate degree in scientific discipline, with advanced degree: MS, PharmD, PhD, M.D. desirable, but not required.
- The candidate must have strong regulatory team leadership experience.
- The candidate should have a strong track record of success in regulatory affairs, with experience in managing regulatory submissions globally. Must have led preparation, submission, prosecution, approval and launch of at least 1 NME via BLA/NDA, and have experience in submission of several sBLA/sNDAs for new indication(s), clinical, labelling, and/or CMC.
- Must have demonstrated ability to influence and gain credibility with internal and external stakeholders.
- Must be flexible and comfortable with ambiguity in a fast-paced, lean company environment.
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. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
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- Job functionScience, Quality Assurance, and Strategy/Planning
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