Director, Regulatory Affairs-Global Regulatory Lead

Immunocore; Gaithersburg (MD); On-site; USD 180,000 - 260,000; Full time

Job summary

Immunocore seeks a Director of Regulatory Affairs to lead regulatory strategy across multiple programs in Gaithersburg, MD; Radnor, PA; and Oxford, UK. You will drive IND/CTA, BLA/NDA submissions, and FDA interactions, coordinating with global teams to ensure compliant, timely filings.

This role requires extensive biologics regulatory expertise and decisive leadership in a fast-paced setting. You will oversee regulatory planning, submit documents, monitor global requirements, and mentor teams to

Qualifications

• Solid track record in drug development and leadership within a dynamic project team.
• Strong understanding of global regulatory requirements for regulatory strategies.
• Excellent knowledge of US regulatory requirements with submissions experience.
• Experience in supporting global clinical studies.
• Experience submitting INDs/CTAs, BLAs/NDAs, and MAAs; at least 1 NME BLA/NDA desirable.
• Experience in Health Authority Meetings and liaison with FDA and global authorities.
• Demonstrate agility to adapt to changing priorities.
• Proven leadership with strong communication and interpersonal skills.

Responsibilities

• Provide regulatory leadership to cross-functional development project teams to achieve strategic objectives.
• Responsible for US and ex-US regulatory activities for the project teams.
• Develop regulatory scientific and tactical plans and target labelling for product development.
• Lead creation of regulatory submission documents (IND/CTA, CTD/BLA/MAA) for eCTD submissions.
• Manage submission of regulatory documentation to US and international authorities.
• Act as center of excellence for global regulatory requirements, especially US; monitor regulatory environment.
• Contribute to procedures and practices for late-stage development and commercialization.
• Oversee regulatory review of clinical trial labelling and CMC submissions with the Director of Regulatory CMC.
• Demonstrate professionalism, leadership, critical thinking, and data-supported conclusions.
• Review and ensure the quality of detailed scientific information with adequate evidence.

Skills

Drug development leadership

Global regulatory knowledge

US regulatory knowledge

Global clinical studies

IND/CTA/BL/NDA/MAA submissions

Health Authority meetings

Agility

Leadership & communication

Education

Advanced degree preferred

BS with 8-12 years experience

Job description

Location of roleGaithersburg, MD, Radnor, PA, Oxford, UK

Department Regulatory Affairs

Key Responsibilities 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

1. 2. Time Management.
2. 4. Personal Effectiveness/Credibility.
3. 5. Flexibility.
4. 6. Technical Capacity.
5. 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.