ProductLife Group is a global consulting and outsourcing partner to the life sciences industry. We support pharmaceutical and biotechnology companies across the full product lifecycle, from early development through post-marketing activities.
We are looking for an experienced Senior Director / Principal Consultant – Regulatory Strategy to lead U.S. and Canadian regulatory development programs, with strong expertise in Health Canada requirements and pathways.

Responsibilities:

Regulatory strategy & leadership

  • Lead regulatory strategy and execution for U.S. FDA and Health Canada development programs.
  • Provide senior-level regulatory guidance for pre-clinical through late-stage development programs.
  • Develop regulatory assessments, integrated development plans, and strategic documentation.

Health Authority interactions & submissions

  • Lead preparation and oversight of Health Authority meeting packages, special designation requests, and regulatory submissions (including IND-enabling and CTA-related documentation).
  • Serve as Authorized Sponsor Representative, including leading and participating in formal FDA and Health Canada meetings.
  • Provide meeting strategy, preparation, and coaching to clients.

Program & project leadership

  • Act as regulatory project lead for complex, cross-functional programs.
  • Coordinate regulatory activities across Clinical, CMC, and Nonclinical functions.
  • Own project timelines, track progress, and proactively identify and mitigate regulatory risks.
  • Communicate clear regulatory status and recommendations to clients and internal teams.

Consulting & business support

  • Provide regulatory intelligence and precedent-based advice, considering U.S., Canadian, and global perspectives.
  • Support proposal development, statements of work, and project scoping.
  • Educate clients on regulatory strategies, Health Canada pathways, and PLG consulting services.
  • Contribute to internal initiatives such as new offerings, process improvements, publications, workshops, and conferences.
  • Mentor and technically guide regulatory colleagues across the organization.

Experience

  • Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field).
  • 15+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry.
  • Proven senior-level experience leading regulatory strategy and execution for development-stage programs.
  • Significant, hands-on Health Authority interaction experience, including Health Canada.
  • Experience managing programs from early development through registration‑enabling stages.
  • Independent development of FDA and Health Canada regulatory strategies.
  • Authoring and oversight of regulatory submissions and Health Authority meeting packages.
  • Direct experience representing sponsors in formal regulatory meetings.
  • Strong knowledge of ICH guidelines, FDA guidance, Health Canada guidance, and global regulatory frameworks.
  • Cross-functional regulatory leadership across Clinical, CMC, and Nonclinical disciplines.
  • Program-level regulatory risk assessment and mitigation.
  • Strong project leadership and coordination skills.

 

The base salary range for this position is $180,000–$250,000 USD. Actual compensation will be determined based on experience, skills, geographic location, and internal equity.

 

Senior Director/Principal Consultant (Regulatory Strategy)

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