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Associate Principal - Regulatory

Lumanity
On-site
Posted 4 days ago
Regulatory-Consultant

AI summary

Lead clinical and regulatory consulting projects, ensuring timely and high-quality client-ready outputs while managing team efforts and client relationships.

Eligible from: Unclear

Job Description

Overview/About Lumanity

Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients’ toughest challenges by revolutionizing how value is generated, demonstrated, and communicated.

Responsibilities / Position overview

The Senior Consultant leads project delivery and workstreams for clinical and regulatory consulting engagements, integrating multiple streams of work into cohesive, high-quality, client-ready outputs. The role applies advanced consulting approaches to synthesize complex data and contextual factors into clear narratives and recommendations, while anticipating client needs and proactively managing expectations with mid-level client stakeholders. The Senior Consultant contributes to business growth by leading proposals and supporting account expansion and strengthens practice performance by coaching junior colleagues and driving internal improvements.

Essential Duties/Responsibilities:

  • Lead assigned engagements from kickoff to final delivery by translating client objectives into actionable workplans, aligning teams to milestones, and driving execution to ensure delivery is on time and meets client needs.
  • Integrate multiple workstreams into cohesive, decision-ready outputs by synthesizing findings across analyses, ensuring internal consistency of storyline and evidence, and aligning deliverables to the client’s decision context.
  • Ensure rigorous quality control across project outputs by applying thorough review, resolving inconsistencies, and confirming deliverables are clear, accurate, and client-ready prior to final sign-off.
  • Apply advanced consulting approaches to synthesize complex data and contextual factors into clear, actionable narratives and recommendations by anticipating what the client needs to decide and tailoring outputs accordingly.
  • Lead sub-teams to address complex client questions by structuring analyses, adapting analytical frameworks to novel challenges, and coaching team members to improve rigor and pace.
  • Proactively guide internal and client-facing discussions by framing key decision points, surfacing trade-offs, and strengthening recommendation credibility through clear, structured rationale.
  • Own mid-level client relationships by maintaining regular communication, proactively managing expectations, and addressing issues early to protect timelines, quality, and client satisfaction.
  • Oversee project budgets and scope to ensure profitable delivery by monitoring effort/burn, managing change control, applying sound commercial judgement in delivery decisions, and prioritizing value-add work aligned to client outcomes and project economics.
  • Lead proposal development by shaping the approach, drafting and coordinating high-quality proposal content aligned to client needs and decision criteria, and support account expansion by identifying adjacent needs and coordinating next-step opportunities with account leadership/
  • Integrate scientific/clinical/regulatory/quality expertise into strategic recommendations to strengthen feasibility and defensibility while building recognition in a therapy area/offering; coach junior colleagues through clear direction and actionable feedback; and lead internal projects that improve templates, ways of working, and delivery standards.

Qualifications

  • Bachelor's degree in a relevant discipline (e.g., life sciences, biomedical sciences, pharmacology, immunology, oncology, public health, epidemiology, health outcomes, or related field) required.
  • 4-7 years relevant experience in life sciences consulting and/or within pharma/biotech/clinical research/regulatory environments, with demonstrated ability to lead project delivery and manage complex analyses.
  • Prior experience leading projects, ensuring quality control, and integrating multiple streams of work into cohesive client-ready outputs.
  • Strategic and critical thinking skills, including the ability to adapt frameworks to novel challenges and coach others in structured problem solving.
  • Strong client relationship capabilities, including owning mid-level stakeholder relationships and proactively managing expectations and delivery risk.
  • Strong commercial acumen, including oversight of project budgets and scope to ensure profitable delivery and sound commercial stewardship.
  • Demonstrated ability to lead proposals and contribute to account expansion through opportunity identification and strong written proposal development.

We offer our employees a comprehensive benefits package that focuses on what matters to you – health and well-being, personal finances, professional development, and a healthy work/life balance:

  • Competitive salary
  • Medical, dental, and vision insurance options
  • 401(k) plan with employer match
  • Generous amount of paid time off annually + 10 paid holidays
  • Employee Assistance Program
  • Company-paid short-term and long-term disability coverage
  • Flexible spending accounts for health and dependent care and more...

Originally posted on Himalayas

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About the job

Posted on
Oct 19, 2026
Job type
Full-time
Location
United StatesOn-site

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