Regulatory Project Manager

Eliquent Life Sciences, Inc
87d

About The Position

We are seeking a skilled and proactive Project Manager to lead consulting and operational projects within the Life Sciences sector, with a focus on Regulatory Affairs, Quality Assurance, and Compliance. This role combines strategic project leadership with hands-on execution, including contract management, financial oversight, and client engagement. The ideal candidate will have a strong understanding of regulatory environments and a proven ability to deliver profitable, compliant, and high-impact projects.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, Business, or related field (Master’s preferred).
  • 8-10 years of project management experience, preferably in the life sciences industry.
  • Experience in Regulatory Affairs, Quality Assurance, or Compliance projects.
  • Strong background in contract management and project financial oversight.
  • PMP or equivalent certification preferred.
  • Excellent communication, negotiation, and leadership skills.
  • Proficiency in project management tools and financial tracking systems.

Responsibilities

  • Manage the full lifecycle of consulting and operational projects, from initiation through closure.
  • Define project scope, objectives, deliverables, timelines, and resource plans.
  • Lead cross-functional teams to ensure timely and quality delivery.
  • Serve as the primary liaison between clients and internal teams.
  • Ensure alignment on project goals, timelines, and deliverables.
  • Identify opportunities for account growth and additional services.
  • Apply knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.) and quality standards (GxP, ISO).
  • Ensure all project activities comply with applicable regulations and industry best practices.
  • Support contract development, negotiation, and execution in collaboration with legal and business teams.
  • Monitor contract terms, deliverables, and obligations to ensure compliance.
  • Manage change orders, scope adjustments, and contract amendments as needed.
  • Develop and manage project budgets, forecasts, and financial performance metrics.
  • Track project costs, resource utilization, and profitability.
  • Identify and mitigate financial risks; ensure projects meet margin targets.
  • Maintain accurate project documentation, including plans, reports, and regulatory records.
  • Provide regular updates to internal and external stakeholders on project status, risks, and financials.

Benefits

  • Attractive salary and comprehensive benefits package for full-time employees, including health, dental, vision, and life insurance.
  • 401(k) plan with employer match.
  • Generous paid time off policy.
  • Additional perks.
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