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Senior Director/Principal Consultant (Regulatory Strategy)

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Product Life Group

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Location:
United States

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

180000.00 - 250000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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

Requirements:

  • 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

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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