OneTrust

Director, Regulatory Policy – North America

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • District of Columbia • New Jersey • United States

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Salary

💰 $150,000 - $258,750 per year

Job Level

Lead

About the role

  • Lead the assessment and synthesis of U.S. regulatory intelligence, identifying emerging trends, legislative changes, and strategic opportunities.
  • Ensure targeted dissemination of insights to internal stakeholders, enhancing regulatory strategy and decision-making.
  • Translate complex regulatory developments into actionable guidance for regional and global teams.
  • Develop and drive effective approaches to U.S. regulatory policy initiatives, with a specific focus on digital health in pharmaceutical drug development and/or Artificial Intelligence.
  • Actively participate in regulatory commenting system, driving aligned internal perspectives, and coordinating company responses to draft regulations and guidance.
  • Collaborate cross-functionally to develop and implement influencing strategies that shape the future healthcare environment.
  • Provide strategic input to global working groups and policy platforms, integrating regional perspectives.
  • Represent the company in regional and global trade associations, professional organizations, and regulatory policy forums.
  • Engage directly with health authorities and government bodies to advocate for science-based, innovation-friendly regulatory policies.
  • Build and maintain trusted relationships with external stakeholders to advance the company’s policy positions.
  • Serve as a visible and credible regulatory policy leader both internally and externally.
  • Partner with Legal, Government Affairs, R&D, and Commercial teams to ensure policy alignment and strategic integration.
  • Mentor and guide junior policy staff, fostering a culture of regulatory excellence and proactive engagement.

Requirements

  • A minimum of a Bachelor’s degree in Regulatory Affairs, Public Policy, Law, Life Science, or a related discipline is required.
  • An advanced degree (Master’s, PharmD, Ph.D., J.D.) in Regulatory Affairs, Public Policy, Law, Life Sciences, or a related discipline is preferred.
  • A minimum of 10 years of experience in regulatory policy, government affairs, or regulatory strategy within the biotechnology or pharmaceutical industry is required.
  • Experience engaging with major health authorities (e.g., FDA, Health Canada) is required.
  • Demonstrated experience in influencing regulatory environments and shaping policy outcomes is required.
  • Strong understanding of global regulatory systems is required.
  • Strong knowledge of healthcare policy landscapes is required.
  • Experience with digital health and/or artificial intelligence (AI) is preferred.
  • Familiarity with regulatory frameworks for emerging technologies (e.g., cell and gene therapy, digital health, AI in medicine) is preferred.
  • Global policy experience is preferred.
  • Must have excellent oral and written communication skills.
  • Must have strong negotiation and stakeholder management skills.
  • The ability to lead cross-functional initiatives and influence decision-making in a matrixed organization.
Benefits
  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • 401(k)
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory policygovernment affairsregulatory strategydigital healthartificial intelligenceregulatory frameworkshealthcare policyglobal regulatory systemsinfluencing regulatory environmentspolicy outcomes
Soft skills
oral communicationwritten communicationnegotiationstakeholder managementcross-functional leadershipstrategic inputmentoringrelationship buildingproactive engagementcollaboration
Certifications
Bachelor’s degreeMaster’s degreePharmDPh.D.J.D.