Responsibilities

  • Serve as a senior regulatory advisor and Regulatory Lead for biotechnology, pharmaceutical, and medical device client engagements.
  • Independently develop, refine, and execute regulatory strategies aligned with client development objectives, regulatory milestones, and submission plans.
  • Lead complex, multidisciplinary regulatory projects and programs by defining workplans, timelines, budgets, assumptions, resource requirements, and delivery approaches.
  • Lead, coordinate, author, and review key regulatory documents, including:
    • Health Authority meeting packages and briefing documents
    • Special designation requests
    • INDs, NDAs, BLAs, CTAs, and amendments
    • Responses to Health Authority questions
    • Regulatory correspondence
  • Support, lead, or participate in formal interactions with Health Authorities on behalf of clients, including:
    • Developing meeting strategies
    • Preparing and coaching clients for Health Authority meetings
    • Serving as Authorized Sponsor Representative when required
  • Interpret and apply FDA, Health Canada, ICH, GxP, and global regulatory guidance, requirements, industry standards, and precedents.
  • Coordinate cross-functional client and internal teams, including Clinical, CMC, Nonclinical, Quality, Regulatory Operations, Medical Writing, and Program Management.
  • Oversee multiple regulatory workstreams and ensure alignment across submissions, deliverables, decisions, and timelines.
  • Monitor project progress and proactively identify regulatory, operational, resourcing, timeline, and client-delivery risks.
  • Develop practical risk-mitigation plans and communicate project status clearly to clients and internal stakeholders.
  • Contribute regulatory expertise to project scoping, proposals, statements of work, budget assumptions, timelines, and resource planning.
  • Support business development by presenting PLG's regulatory capabilities and identifying opportunities for continued or expanded client partnerships

Requirements

  • Bachelor's degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline.
  • An advanced degree and/or regulatory certification is preferred but not required.
  • Minimum of 10–12 years of progressive Regulatory Affairs experience within biotechnology, pharmaceuticals, medical devices, or life sciences consulting.
  • Demonstrated experience developing and executing regulatory strategies for development-stage programs, ideally from early development through registration or marketing approval.
  • Experience leading or supporting Health Authority interactions, including FDA and/or ex-U.S. agency meetings, briefing packages, responses, and regulatory correspondence.
  • Experience authoring, reviewing, coordinating, or leading major regulatory submissions, such as INDs, NDAs, BLAs, CTAs, amendments, special designation requests, and Health Authority meeting packages.
  • Strong knowledge of FDA and global regulatory guidance, ICH expectations, GxPs, and relevant industry trends.
  • Strong project and program management capabilities, including timeline ownership, workstream coordination, budget and resource awareness, risk identification, and mitigation planning.
  • Demonstrated ability to coordinate cross-functional teams and manage multiple regulatory deliverables, workstreams, timelines, and competing priorities.
The base salary range for this position is $160,000–$190,000 USD. Actual compensation will be determined based on experience, skills, and internal equity.

Publish Date

06 August, 2026

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Senior Regulatory Affairs Consultant - VAF 635

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