Hybrid Director, Regulatory Policy Research and Operations

at OneTrust

• Job title: Director, Regulatory Policy Research and Operations
• Job type: Full Time
• Experience level: Lead
• Salary: $150,000 - $258,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Raritan, United States

About the role

• Director leading regulatory policy research and operations at Johnson & Johnson. Accountable for scientific research coordination and regulatory intelligence oversight with a hybrid work model.

Responsibilities

• 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