Associate Director, Regulatory Affairs

Location

Oxford, UK

Department

Regulatory Affairs

Key Responsibilities

The Associate 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 and leadership for standardization of certain processes to improve efficiency, flexibility and consistency across projects. The role will align with the Regulatory Affairs Head of Tactical on the assignment of products based on priorities/workload and work closely with the Global Regulatory Leads by providing expertise to Immunocore’s development programs to include: regulatory implementation of regulatory strategies, IND/CTA development/submission/maintenance/tracking, BLA/sBLA/MAA/Variations planning submission/maintenance/tracking, agency liaison for specific tactical assignments, and regulatory intelligence for tactical/process related changes in requirements. This role also involves interacting with our global sites, both in-house and outsourced.

The ideal candidate will have experience gained in biologics and the preparation of early and late stage regulatory fillings supported by excellent leadership skills. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to provide input into the execution of regulatory strategies through effective collaboration and be able to deliver and work well under pressure as this will be a high-profile role.

Responsibilities

• Provide regulatory leadership and support to cross-functional development for projects to jointly achieve strategic objectives.
• Deliver US, EU and global regulatory submission activities across the Immunocore portfolio.
• Provide input into the implementation of regulatory tactical strategies to support development of products in alignment with agreed strategies.
• Manage, prepare, co-ordinate and be responsible for the submission of documentation supporting regulatory submissions to the US, EU and wider international regulatory authorities, in support of CTA/INDs, BLAs/MAAs, safety reports and updates, along with all other regulatory submissions, working with the Global Regulatory Leads and Regulatory Operations.
• Act as the center of excellence (point of contact) for all regulatory requirements and guidelines globally and conduct regulatory intelligence to anticipate changes in laws, guidance, and standards that impact tactical implementation.
• Assess impact on products/processes and communicate findings from a tactical requirement(s).
• Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in development.
• Demonstrate a high level of professionalism, efficiency and leadership within the team while demonstrating critical thinking, effective problem solving and a strong knowledge of planned/approved regulatory strategies and alignment with all necessary compliance.

Supervisory Responsibility

This position has no supervisory responsibilities

Competencies

• Communication Proficiency both written and oral
• Time Management
• Collaboration Skills
• Personal Effectiveness/Credibility
• Flexibility
• Technical Capacity
• Stress Management/Composure

Experience & Knowledge

Essential

• Solid track record in drug development and regulatory implementation within a dynamic project team(s)
• Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory implementation
• Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally
• Excellent knowledge of US and EU regulatory requirements and 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
• Administrative interaction with Health Authorities and/or the health authority project manager level
• 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. Contribution to part of the submission of at least 1 NME BLA/NDA is highly desirable but not required
• Experience in supporting global Health Authority Meetings (FDA, European: National or EMA), such as preparing/changing presentations, taking minutes, managing logistics

Education & Qualifications

Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with a minimum of 3 years’ experience. BSc with 5-10 years’ experience.

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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