Vice President, Regulatory Affairs

Key ResponsibilitiesReporting 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.