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 & Tools
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.