ProductLife Group (PLG) is a global life sciences consulting and outsourcing partner supporting pharmaceutical, biotechnology, and medical device companies throughout the full product lifecycle. 

We are looking for an experienced Regulatory Affairs CMC Expert (Senior Consultant) to lead U.S. regulatory CMC strategy and execution for biotechnology and pharmaceutical clients, in all phases of development across drugs and biologics.

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.

Senior Regulatory Affairs Consultant

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