Hybrid Director, Regulatory Policy Research – Operations

at Johnson & Johnson

• Job title: Director, Regulatory Policy Research – 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 of Regulatory Policy Research and Operations overseeing scientific research and intelligence activities. Leading team efforts to advance regulatory policy strategies for Johnson & Johnson's Innovative Medicine.

Responsibilities

• Lead, provide, and coordinate scientific research support for GRA and GRPI policy positions and initiatives.
• Utilize scientific and policy expertise to offer comprehensive research and policy support to GRPI leaders and policy leaders.
• Oversee the regulatory intelligence function, ensuring that the team provides timely and relevant insights.
• Coordinate and manage training programs related to regulatory intelligence.
• Conduct or coordinate research for various outputs including publications, presentations, and policy positions.
• Ensure research activities align with organizational goals and regulatory requirements.
• Support the policy team’s coverage of trade association policy activities and other external policy groups as needed, ensuring alignment with company objectives.
• 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 on health authority documents and global initiatives.
• Support the Head GRPI with functional governance activities including strategy and goal setting, resource management, capability building, and overall team engagement.
• Oversee the GRPI website and related tools, ensuring they are up-to-date and effectively support GRPI activities.
• Manage meeting logistics and communication activities.
• 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.
• Serve as a member of the GRPI Leadership Team (LT), contributing to strategic planning and decision-making processes.
• Work with cross-functional leaders and partners to advance policy initiatives, ensuring coordination and alignment across the organization.

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; 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