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 seeking a Service Line Lead – NAM Regulatory Development & Sciences to hold full accountability for the performance, delivery, and growth of PLG’s Regulatory Affairs Service Line in North America

Responsibilities:

 

Service line leadership & accountability

  • Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line.
  • Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction.
  • Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements.
  • Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations.

Regulatory strategy & subject‑matter leadership

  • Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing.
  • Act as senior regulatory SME for complex and high‑impact programs.
  • Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations.
  • Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required.
  • Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions.

Commercial & financial management

  • Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization.
  • Partner closely with Commercial teams to support sales calls, proposals, scoping, pricing input, and bid defenses.
  • Support sustainable growth of the service line through disciplined commercial decision-making.

People leadership & capability building

  • Lead capacity planning, resource allocation, and talent deployment in collaboration with staffing and operations.
  • Lead, mentor, and develop senior regulatory professionals in a matrix consulting environment.
  • Support performance management, engagement, succession planning, and retention.
  • Contribute to evolution of service offerings, process improvements, and approved capability roadmaps.
  • Represent the Service Line in internal governance forums and selected external or industry-facing engagements.

Experience

  • Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field).
  • Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred.
  • 20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry.
  • Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization.
  • Proven leadership experience in a consulting, professional services, or matrixed delivery environment.
  • Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks.
  • Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development.
  • Ability to translate regulatory requirements into practical, executable development and submission strategies.
  • Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management.
  • Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

 

The base salary range for this position is $200,000–$260,000 USD. Actual compensation will be determined based on experience, skills, geographic location, and internal equity.

Service Line Lead – NAM Regulatory Development & Sciences

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