OneTrust

Director, Regulatory Policy Research and Operations

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 and coordinate scientific research support for GRA and GRPI policy positions and initiatives.
  • Oversee the regulatory intelligence function, ensuring timely and relevant insights.
  • Conduct or coordinate research for various outputs including publications, presentations, and policy positions.
  • Support the policy team’s coverage of trade association policy activities and other external policy groups.
  • Create and implement tools and strategies to develop and align policy priorities, strategic plans, and other policy documents.
  • Manage GRPI efforts related to commenting programs, developing and submitting company perspectives.
  • Support the Head GRPI with functional governance activities including strategy and goal setting.
  • Oversee the GRPI website and related tools.
  • Provide project management, process, and change leadership for GRPI-driven initiatives.
  • Supervise a small team responsible for regulatory intelligence, communications, and operational support for GRPI.
  • Work with cross-functional leaders and partners to advance policy initiatives.

Requirements

  • A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
  • An advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline is preferred.
  • A minimum of 10 years of experience in the pharmaceutical industry or Contract Research Organization (CRO) is required.
  • A minimum of 4 years of experience in Regulatory Affairs or with Regulatory Policy is required.
  • A minimum of 4 years of direct people management experience is required.
  • Experience working at a major health authority (e.g., FDA) is preferred.
  • Solid understanding of the global regulatory environment, including the U.S., European Union and Asia Pacific, is preferred.
  • Understanding of global regulatory systems is preferred.
  • Knowledge of healthcare policy landscapes is preferred.
  • Experience with digital health and/or artificial intelligence (AI) is preferred.
  • Strong computer skills, with the ability to work with programs such as Smartsheet and SharePoint, required.
  • 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
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 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 affairsregulatory policyproject managementscientific researchhealthcare policydigital healthartificial intelligenceregulatory intelligencestrategic planningpeople management
Soft skills
communicationnegotiationstakeholder managementleadershipcross-functional collaborationinfluencechange leadershiporganizational skillsteam supervisiongoal setting