Senior Director, Regulatory Affairs

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

Job summary

Immunocore is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy for late-stage programs in the US, based in Gaithersburg, MD. You will oversee IND/CTA and BLA submissions, liaise with the FDA, and guide global regulatory activities across development teams.

The ideal candidate has deep biologics regulatory experience, strong leadership, and a proven ability to deliver complex filings under pressure in a fast-paced, global setting.

Qualifications

• Solid track record in drug development and leadership within project teams.
• Extensive regulatory experience for biologics and late-stage filings.
• Strong understanding of US and global regulatory requirements.

Responsibilities

• Provide regulatory leadership and support to cross-functional development project teams to achieve objectives.
• Be responsible for US regulatory activities associated with the project teams.
• Develop regulatory scientific and tactical strategies and target labelling.
• Lead development and writing of regulatory submission documents (IND/CTA, BLA/NDA, CTD/eCTD).
• Manage submissions to US and international authorities for CTA/INDs, BLAs/NDAs, MAAs.
• Act as center of excellence for global regulatory requirements, especially in the US.

Skills

Regulatory strategy

FDA liaison

Leadership

Biologics experience

IND/CTA/BLA

Education

Advanced degree

Job description

Location of role

Gaithersburg, MD, Radnor, PA

Department

Regulatory Affairs

Key Responsibilities

The Senior 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, and MHRA providing a fantastic and unique opportunity to develop worldwide regulatory experience.

The ideal candidate will have experience gained in biologics and the preparation of 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 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.

This role will be responsible for presentations of proposed scientific and tactical regulatory strategies at Immunocore governance meetings, with an ability to make appropriate changes based on feedback leading to full alignment. This role will also be responsible for providing regulatory leadership for implementation of plans within a project team, including leadership for all health authority interactions globally. As the organization grows this role will be responsible for overseeing, guiding and mentoring direct reports for their assigned projects, either as support for the same assigned project and/or for another assigned project. The role will also provide review/guidance and approval for direct reports and dotted line reports regulatory tactical and administrative plans to ensure consistency across the organization. This role will also provide preliminary review of direct reports regulatory scientific strategies and discuss with Head of Regulatory Sciences to gain alignment prior to governance meeting review(s).

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 regulatory activities associated with the project teams.
• Develop regulatory scientific and tactical strategies and target labelling to support development of products.
• Provide leadership for the development and writing of regulatory submission documents, ex. 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, anti-infectives, autoimmune diseases, 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 junctions 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 alignment with all necessary compliance.
• 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.
• To review and provide input/guidance and approval for tactical and administrative plans for more junior level global regulatory leads and ensure consistency of implementation across the organization. This will be for both direct reports and others with a dotted line reporting for such reviews.
• Provide input/guidance for scientific regulatory strategies for direct reports and discuss with the Head of Regulatory Sciences prior to governance meetings to ensure alignment.

SUPERVISORY RESPONSIBILITY

This position may include line manager responsibilities for direct reports and dotted line reporting

• Leads a review and approval of tactical and administrative regulatory plans to ensure global consistency of both direct reports and dotted line reports for these regulatory aspects.
• Provides guidance to direct reports for scientific regulatory strategies and gains alignment with Head of Regulatory Sciences.
• Promotes communication and cooperation among functions to create a spirit of unity in the organization

EXPERIENCE & KNOWELEDGE

• Solid track record in drug development and leadership within a dynamic project team(s)
• Solid scientific background with evidence of ability to develop regulatory scientific strategies.
• Strong understanding of global regulatory requirements to be able to form tactical 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 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 8-12 years’ experience or BS with 10-15 years’ experience.