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Director of Regulatory Affairs,Tactical and Implementation

Immunocore, Gaithersburg, MD, United States

Location of role Gaithersburg, MD, Radnor, PA

Department Regulatory Affairs

The Director of Regulatory Affairs will be responsible for leadership and oversight of the Regulatory Tactical Implementation team within Regulatory Affairs. Providing leadership for standardization of certain processes to improve efficiency, flexibility and consistency across projects. Mentoring individuals within the group and making project assignments with the Global Regulatory Leads and VP of Regulatory based on priorities/workload and individuals expertise/experience. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocore’s development programs to include: regulatory implementation of regulatory strategies, IND development/submission/maintenance/tracking, BLA/sBLA planning submission/maintenance/tracking, agency liaison for specific tactical assignments, and regulatory intelligence for tactical/process related changes in requirements. The role will also involve interacting with our global sites, both in-house and outsourced. Responsible for overseeing tactical implementation of global regulatory submissions to Health Authorities, providing a fantastic and unique opportunity to develop a team with worldwide regulatory experience.

The ideal candidate will have experience gained in biologics and the preparation of early and late stage regulatory fillings supported by excellent leadership and people management 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.

KEY RESPONSIBILITIES

  • Provide coaching/skill development and performance feedback for regulatory staff in the tactical implementation group.
  • To provide regulatory leadership and support to cross functional development for projects to jointly achieve strategic objectives.
  • To be responsible for overseeing the delivery of US and EU regulatory submission activities across the Immunocore portfolio
  • Lead resource planning and training of direct reports
  • Provide input into the implementation of regulatory tactical strategies to support development of products in alignment with agreed strategies.
  • 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/MAAs, CTA safety reports and updates, along with all other regulatory submissions working with the Global Regulatory Leads and Regulatory Operations
  • To be the center of excellence (point of contact) of 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.
  • Contribute to the establishment and development of procedures and working practices commensurate with the requirements of a company in development.
  • 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.

SUPERVISORY RESPONSIBILITY

This position has supervisory responsibilities

COMPETENCIES

  1. Talent management
  2. Communication Proficiency both written and oral
  3. Time Management.
  4. Personal Effectiveness/Credibility.
  5. Flexibility.
  6. Technical Capacity.
  7. Stress Management/Composure.

IMMUNOCORE VALUES – ALL STAFF

  • 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 & knowledge

  • Solid track record in drug development and leadership within a dynamic project team(s)
  • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies.
  • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally.
  • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval.
  • Excellent knowledge of US 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
  • Health Authorities and 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 the preparation and conduct of Health Authority Meetings (FDA)
  • Coaching and mentoring direct reporting regulatory affairs staff, including identification of skill development opportunities for regulatory professionals with different levels of experience.

Advanced degree preferred – M.S., PharmD, Ph.D., or M.D. with a minimum of 5 years’ experience. BS with 8-10 years’ experience.

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