Hybrid Manager, Regulatory Policy Research

at OneTrust

• Job title: Manager, Regulatory Policy Research
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $102,000 - $177,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Raritan, United States

About the role

• Manager, Regulatory Policy Research supporting Global Regulatory Affairs initiatives at Johnson & Johnson. Conducting research, coordinating resources, and enhancing policy strategies within a hybrid work culture.

Responsibilities

• Conduct scientific and policy research to support GRPI and GRA initiatives, positions, and ad-hoc queries
• Deliver comprehensive research and policy resources to GRPI leaders and policy leads
• Provide regulatory intelligence support to GRPI and GRA, ensuring that the team provides timely and relevant insights
• Coordinate and manage training programs related to regulatory intelligence
• Conduct research for various outputs including publications, presentations, and policy positions
• Ensure research activities align with organizational goals and regulatory requirements
• Create and implement tools to support policy priorities, strategic plans, and other policy documents
• Identify opportunities to use technologies to simplify policy team processes and approaches
• Develop, implement, and drive adoption of technology tools to support policy priority-setting and strategic planning
• Manage cross-functional participation in commenting tools, ensuring proper document retention, archived guidances, and user support
• Support development and maintenance of the GRPI website and related tools
• Support the policy team’s coverage of trade association policy activities and other external policy groups as needed
• Track and report on trade association policy activities and external policy group engagements
• Partner with policy leads to plan and execute regulatory policy workshops on high-priority policy topics
• Provide support related to consultant purchase orders and invoices, ensuring timely payment and accurate recordkeeping

Requirements

• A minimum of a Bachelor’s degree in a scientific or technical discipline
• An advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline is preferred
• A minimum of 4 years of experience in the pharmaceutical industry or Contract Research Organization (CRO) is required
• A minimum of 2 years of experience in Regulatory Affairs Policy support 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
• Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Teams) is required
• 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 manage multiple priorities and work cross-functionally in a global, matrixed environment

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; 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