Johnson & Johnson Innovative Medicine · 19 hours ago
Manager, Regulatory Policy Research (1 of 2)
Raritan, NJ
Full-time
Hybrid
Mid, Senior Level
$102K/yr - $177K/yr
4+ years expJohnson & Johnson Innovative Medicine is a leader in healthcare innovation, dedicated to developing treatments and pioneering solutions for complex diseases. The Manager, Regulatory Policy Research will support the Global Regulatory Policy and Intelligence team by conducting scientific and policy research, managing internal tools, and coordinating regulatory resources.
Pharmaceuticals
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, under leadership of PRO Director, to support policy priorities, strategic plans, and other policy documents
Identify opportunities to use technologies to simplify policy team processes and approaches
Develop, successfully implement, and drive adoption of technology tools to support policy priority-setting and strategic planning
Support GRPI-led commenting efforts on health authority documents and global regulatory initiatives
Manage cross-functional participation in the commenting tools, ensuring proper document retention, archived guidances, and user support
Support development and maintenance of the GRPI website and related tools, ensuring they are up-to-date and effectively support GRPI activities
Manage meeting logistics and communication activities
Support the policy team’s coverage of trade association policy activities and other external policy groups as needed, ensuring alignment with company objectives
Track and report on trade association policy activities and external policy group engagements
Manage meeting logistics, communications, and follow-ups for internal and external policy engagements
Partner with policy leads to plan and execute regulatory policy workshops on high-priority policy topics
Provide support to PRO Director related to consultant purchase orders and invoices, ensuring timely payment and accurate recordkeeping
Support annual contract renewals and scopes of work for GRPI consultants
Qualification
Required
A minimum of a Bachelor's degree in a scientific or technical discipline
A minimum of 4 years of experience in the pharmaceutical industry or Contract Research Organization (CRO)
A minimum of 2 years of experience in Regulatory Affairs Policy support
Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Teams)
Strong computer skills, with the ability to work with programs such as Smartsheet and SharePoint
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
Preferred
An advanced degree (Master's, PharmD, Ph.D.) in a scientific or technical discipline
Experience working at a major health authority (e.g., FDA)
Solid understanding of the global regulatory environment, including the U.S., European Union and Asia Pacific
Understanding of global regulatory systems
Knowledge of healthcare policy landscapes
Experience with digital health and/or artificial intelligence (AI)
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
Company data provided by crunchbase