VP, Drug Regulatory Affairs

Reports to: Chief Medical Officer

Job type: Full-time

Location: Hybrid: London Bioscience Innovation Centre, Kings Cross, London, UK, and working from home

Prokarium is recruiting for an experienced VP, Drug Regulatory Affairs to join our diverse and high- performance team. Under the direction of the Chief Medical Officer (CMO) you will be responsible for leading all interactions with regulators and liaising closely with the Clinical Development, CMC Manufacturing, Quality, Translational, and Preclinical teams/consultants in the company. The initial focus will be our lead program, a novel microbial immunotherapy for the treatment of Non-Muscle Invasive Bladder Cancer. You will drive the creation, implementation and execution of all regulatory matters and work with the CMO, VP Research, VP CMC and Directors of Clinical Development and Translational Research to develop a detailed regulatory package for submission in the UK, EU, CH or US. You will need to have a strategic mindset to ensure regulatory preparedness and compliance through interaction with regulators, contractors and internal team members.

Based in central London, you will be a vital part of developing and executing our regulatory strategy.

Key responsibilities

  • Be the all-round regulatory lead (clinical / non-clinical / CMC / GxP) for early-stage drug development projects
  • Lead all regulatory authority interactions, including national and regional level interactions
  • Organise cross functional teams to construct the relevant regulatory documents for early-stage therapeutics: CTAs, INDs, PIPs, scientific advice
  • Assist with the preparation and submission of regulatory submissions for assigned products in line with national/regional regulatory requirements
  • Coordinate and ensure timely completion of regulatory reviews of all clinical study documents requiring regulatory input (e.g. study protocols and amendments, IB, etc.)
  • Provide regulatory input into the study setup, including country feasibility and ensuring adherence to local requirements and legislation
  • Ensure all agency correspondence and commitments are appropriately tracked and archived in accordance with Prokarium’s procedures, or develop new procedures as necessary
  • Collect, share and interpret emerging regulations, ensure alignment with clinical development and CMC strategy
  • Develop and update contingency plans for issues that affect study initiation and registration scenarios especially as it relates to CTA and IND activities and ensure strategy is in alignment with clinical development plan, CMC strategy, and the Target Product Profile
  • Establish a Rapid Response Team as necessary to develop and obtain alignment on strategy for responses to regulatory authorities
  • Develop internal partnerships with key operational departments: CMC, Preclinical, Translational, and Clinical, and thrive in a cross-functional team to achieve corporate goals
  • Exhibit ownership and accountability for projects and internal assignments

Qualifications, Experience and Competencies

  • Minimum of MSc or equivalent degree is required
  • Advanced degree (PhD, MD or Pharm D) strongly preferred (Regulatory Affairs Certification Drugs (RAC) is a plus)
  • Minimum 10 years of previous regulatory affairs in a biotech or pharma is required
  • A strong technical understanding of the Regulatory Affairs industry is required
  • Recent direct experience of oncology clinical development is desirable
  • Experience leading regulatory submissions such as CTAs, INDs (form 1571/eCTD), and Scientific Advice required. Excellent understanding of and ideally experience with accelerated registration processes (FDA accelerated approval, EMA conditional marketing access, etc.)
  • Awareness of regulatory landscape for assigned geographic region, including ICH and regional requirements for assigned territories and current regulatory trends
  • Deep understanding of drug development stages specifically for early-stage therapeutics (non-clinical, CMC, translational, Phase 1)
  • Ability to skilfully represent Prokarium and our products with regulatory authorities required
  • Demonstrated history of taking calculated risks resulting in innovative, successful regulatory interactions
  • Passion for developing new therapies in a fast-changing SME environment
  • Excellent written and verbal English communication skills