Johnson & Johnson Innovative Medicine · 4 days ago
Director, Regulatory Policy Research and Operations
Washington, DC
Full-time
Hybrid
Director/Executive
$150K/yr - $259K/yr
10+ years expJohnson & Johnson Innovative Medicine is dedicated to healthcare innovation that aims to prevent, treat, and cure complex diseases. The Director, Regulatory Policy Research and Operations will lead scientific research and intelligence activities for Global Regulatory Affairs, supporting regulatory policy strategies and team management.
Pharmaceuticals
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
Qualification
Required
A minimum of a Bachelor's degree in a scientific or technical discipline is required
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
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
Preferred
An advanced degree (Master's, PharmD, Ph.D.) in a scientific or technical discipline is preferred
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
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
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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