Responsibilities

  • Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements with a focus on CMC in all phases of development
  • Develop and drive CMC regulatory strategies, integrated development plans, and key CMC regulatory documents
  • Coordinate, author, review, and manage:
    • Health Authority meeting packages
    • Special designation requests
    • Regulatory submissions (INDs, NDAs, BLAs, amendments)
  • Lead and represent clients in formal FDA interactions, including:
    • Acting as Authorized Sponsor Representative
    • Preparing and coaching clients for Health Authority meetings
  • Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks
  • Act as project lead on complex, multi-disciplinary regulatory programs:
    • Define scope, timelines, budget, and resource plans
    • Monitor risks and mitigation strategies
    • Communicate project status clearly to clients and internal stakeholders
  • Support business development activities, including proposal and SOW development
  • Contribute to internal initiatives such as:
    • Developing new consulting offerings
    • Publishing articles and presenting at conferences or workshops
    • Process optimization initiatives
  • Mentor and guide internal team members in direct, matrixed, or project-based environments

Requirements

  • Bachelor’s degree (BA/BS) in a relevant scientific discipline
  • 10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
  • Proven experience in:
    • Independent development and execution of U.S. FDA regulatory CMC strategies
    • Authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
    • Direct Health Authority interactions as Sponsor Representative
  • Strong working knowledge of:
    • FDA regulations and guidance
    • ICH guidelines
    • Global regulatory frameworks
  • Demonstrated cross-functional regulatory leadership
  • Experience across multiple development stages (early development through registration)
  • Strong regulatory intelligence and precedent-based decision-making
  • Solid project management skills, including timeline ownership for complex programs
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

04 August, 2026

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Senior Regulatory Affairs Consultant - VAF 543

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