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Service Line Lead – Nam Regulatory Development & Sciences

Plg Groups
PLG groups
20+ years
preferred by company
Remote
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

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

Location: USA (Remote)
Employment Type: Permanent / Full-Time
Department: Product Development / Regulatory Affairs & Operations
Industry: Pharmaceuticals / Biotechnology / Life Sciences Consulting

Job Overview

We are seeking an accomplished Service Line Lead – North America (NAM) Regulatory Development & Sciences to lead the performance, delivery, commercial growth, and strategic direction of a high-impact regulatory affairs consulting service line.

This is a senior leadership role for professionals with deep expertise in global regulatory affairs, regulatory strategy, FDA interactions, client advisory, commercial leadership, P&L ownership, service delivery governance, and senior people leadership.

The successful candidate will hold full accountability for service line execution, business growth, regulatory excellence, client success, and capability development across North America.


Key Responsibilities

Service Line Leadership & Business Accountability

  • Own end-to-end leadership of the Regulatory Development & Sciences Service Line (North America).
  • Drive operational excellence, delivery consistency, and strategic growth.

Accountability includes:

  • Service delivery performance
  • Quality outcomes
  • Client satisfaction
  • Revenue achievement
  • Margin performance
  • Resource utilization
  • Delivery timeliness
  • Ensure service line alignment with global operational and quality standards.

KPI & Performance Management

Own service line performance metrics including:

  • Delivery quality
  • SLA adherence
  • Turnaround timelines
  • Revenue growth
  • Profitability / margins
  • Team utilization
  • Client retention
  • Engagement health
  • Operational efficiency

Monitor performance and implement corrective action plans where required.


Regulatory Strategy Leadership

Lead global regulatory strategy across product lifecycle stages including:

  • Pre-IND
  • Early development
  • Clinical development
  • Registration
  • Post-marketing lifecycle management

Provide strategic leadership for:

  • Pharmaceuticals
  • Biotechnology products
  • Development-stage programs
  • Complex regulatory pathways

Senior Subject Matter Expertise (SME)

Act as senior regulatory SME for:

  • High-complexity programs
  • Strategic client engagements
  • Regulatory risk mitigation
  • Critical development decisions

Serve as interim or on-demand:

  • Head of Regulatory Affairs
  • VP Regulatory Affairs
  • Director Regulatory Affairs

for client organizations when required.


Health Authority Leadership

Lead strategic engagement with health authorities including:

  • FDA
  • Global regulatory agencies

Responsibilities include:

  • Authorized Sponsor Representative duties
  • Regulatory meeting strategy
  • Agency interaction leadership
  • Client coaching for authority meetings
  • Strategic communication planning

Regulatory Submission Oversight

Provide strategic oversight and hands-on leadership for:

  • Health Authority meeting packages
  • Special designation submissions
  • Major regulatory submissions
  • Development documentation
  • Complex regulatory filings

Ensure submission quality, scientific robustness, and strategic alignment.


Commercial Leadership & Financial Ownership

Own full commercial performance of the service line including:

  • Revenue planning
  • Forecasting
  • Budget ownership
  • Margin protection
  • Utilization management
  • Financial performance governance

Drive disciplined commercial decision-making for sustainable business growth.


Sales & Business Development Partnership

Partner closely with commercial and growth teams to support:

  • Client sales discussions
  • Proposal development
  • Solution design
  • Pricing strategy
  • Project scoping
  • Bid defense participation

Support expansion of strategic consulting opportunities.


Client Relationship Leadership

Act as executive escalation point for client engagements.
Balance:

  • Client expectations
  • Commercial goals
  • Delivery feasibility
  • Quality standards
  • Strategic relationship management

Build long-term executive client trust.


People Leadership & Talent Development

Lead senior regulatory consulting teams in a matrix environment.

Responsibilities include:

  • Capacity planning
  • Talent deployment
  • Resource allocation
  • Performance management
  • Team engagement
  • Succession planning
  • Leadership coaching
  • Retention strategy

Mentor senior regulatory professionals and strengthen organizational capability.


Service Offering & Capability Development

Contribute to evolution of:

  • Regulatory consulting service offerings
  • Delivery frameworks
  • Capability roadmaps
  • Process optimization initiatives
  • Operational excellence models

Drive innovation and scalability.


Governance & External Representation

Represent the Regulatory Service Line in:

  • Internal governance forums
  • Leadership committees
  • Strategic operational reviews
  • Industry-facing engagements
  • Selected external thought leadership activities