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Service Line Lead – Nam Regulatory Development & Sciences

Plg Groups
PLG groups
20+ years
preferred by company
Remote, USA, Remote
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Service Line Lead – NAM Regulatory Development & Sciences

Location: United States (Remote Work Available)
Job Type: Full-Time / Permanent Contract
Experience Required: 20+ Years (Freshers are not eligible)
Industry: Regulatory Affairs / Pharmaceutical / Biotechnology / Life Sciences / Product Development
Department: Regulatory Affairs & Operations

About the Role
We are seeking a highly accomplished Service Line Lead – NAM Regulatory Development & Sciences to lead and scale regulatory consulting, delivery excellence, and strategic growth across North America. This executive leadership role is designed for senior regulatory affairs professionals with deep expertise in pharmaceutical and biotechnology product development, global regulatory strategy, health authority engagement, and commercial service line leadership.

The successful candidate will hold full accountability for service line performance, client delivery, commercial growth, regulatory excellence, and operational leadership. This role requires a strategic leader capable of driving regulatory success across the complete product lifecycle—from early clinical development through global commercialization and post-marketing compliance.

This is an exceptional opportunity for experienced regulatory executives seeking leadership roles in consulting, life sciences outsourcing, or global regulatory strategy environments.

Key Responsibilities

Service Line Leadership & Operational Accountability

  • Own end-to-end delivery, performance, and strategic leadership of the North America Regulatory Development & Sciences service line.
  • Drive operational excellence across service delivery, ensuring alignment with organizational quality standards, methodologies, SOPs, and global compliance frameworks.
  • Manage key performance indicators (KPIs) including delivery quality, project timelines, utilization, client satisfaction, profitability, and service performance.
  • Act as the senior escalation point for complex delivery issues, client concerns, and operational challenges.
  • Ensure scalable, consistent, and high-quality execution across all regulatory consulting engagements.

Regulatory Strategy & Scientific Leadership

  • Lead development and execution of global regulatory strategies for pharmaceutical and biotechnology products across all development phases.
  • Provide expert guidance for pre-IND, IND, NDA, BLA, MAA, lifecycle maintenance, and post-marketing regulatory activities.
  • Serve as senior regulatory subject matter expert (SME) for complex product development programs and strategic client initiatives.
  • Function as interim or outsourced Head, VP, or Director of Regulatory Affairs for client organizations when required.
  • Lead regulatory agency interactions with FDA and international health authorities.
  • Support regulatory meeting preparation, submission strategy planning, designation requests, briefing packages, and high-impact regulatory submissions.
  • Translate global regulatory requirements into commercially practical development and approval strategies.

Commercial Leadership & Financial Management

  • Own commercial performance, financial forecasting, budgeting, revenue planning, utilization management, and profitability optimization for the service line.
  • Partner with business development and commercial teams on client acquisition, proposal development, solution design, pricing strategy, and bid defense presentations.
  • Drive sustainable business growth through strategic commercial decision-making and service innovation.
  • Identify expansion opportunities, new client engagements, and high-value consulting opportunities.

People Leadership & Talent Development

  • Lead, mentor, and develop senior regulatory professionals within a matrix consulting environment.
  • Drive workforce planning, talent allocation, capability development, and succession planning.
  • Support performance management, employee engagement, retention strategies, and leadership coaching initiatives.
  • Build high-performing teams aligned with service line growth objectives and delivery excellence.

Governance, Process Excellence & Innovation

  • Represent the regulatory service line in internal governance forums, strategic leadership discussions, and selected external industry engagements.
  • Contribute to service innovation, capability expansion, process optimization, and operating model improvements.
  • Support development of scalable consulting frameworks and regulatory best practices.
  • Ensure compliance with global quality systems and risk management expectations.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Biology, Chemistry, Biotechnology, or a related scientific discipline.
  • Advanced scientific qualification such as PhD, PharmD, MD, or equivalent preferred.
  • 20+ years of regulatory affairs experience within pharmaceutical, biotechnology, biologics, or life sciences organizations.
  • Demonstrated expertise in global regulatory strategy, drug development, biologics development, and lifecycle regulatory management.
  • Strong experience with FDA and international health authority interactions.
  • Proven success leading regulatory consulting, matrixed teams, or professional services delivery environments.
  • Advanced understanding of regulatory submissions, agency engagement strategies, risk management, and compliance frameworks.
  • Strong commercial leadership, business acumen, financial management, and stakeholder leadership capabilities.
  • Excellent executive communication, negotiation, and strategic decision-making skills.