Director, Regulatory Policy Research and Operations

Johnson & Johnson•Columbia, NJ

7h•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Regulatory Policy Research and Operations. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy Research and Operations will be accountable for leading and coordinating scientific research and intelligence activities for Global Regulatory Affairs (GRA) as part of the Global Regulatory Policy and Intelligence (GRPI) group. The role also supports functional governance and team management activities, partnering closely with the Head, GRPI. The Director will lead a small team and drive research efforts across GRPI advancing regulatory policy strategies supporting Johnson & Johnson Innovative Medicine. The work informs creation of policy approaches, helps with decision making, and advances our overall strategic approach. Key to that is collecting, analyzing, organizing, and presenting data about global regulatory programs, issues, and opportunities. This individual will serve on the GRPI Leadership Team, contributing to strategic planning and decision-making processes.

Requirements

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.
This position will require minimal travel.

Nice To Haves

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.

Responsibilities

Scientific Research Support: 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.
Regulatory Intelligence Oversight: Oversee the regulatory intelligence function, ensuring that the team provides timely and relevant insights. Coordinate and manage training programs related to regulatory intelligence.
Research Coordination: Conduct or coordinate research for various outputs including publications, presentations, and policy positions. Ensure research activities align with organizational goals and regulatory requirements.
Policy Team Support: Support the policy team’s coverage of trade association policy activities and other external policy groups as needed, ensuring alignment with company objectives.
Policy Tools and Strategies: Create and implement tools and strategies to develop and align policy priorities, strategic plans, and other policy documents.
Commenting Program Coordination: Manage GRPI efforts related to commenting programs, developing and submitting company perspectives on health authority documents and global initiatives.
Governance: Support the Head GRPI with functional governance activities including strategy and goal setting, resource management, capability building, and overall team engagement.
Website and Tools Management: Oversee the GRPI website and related tools, ensuring they are up-to-date and effectively support GRPI activities. Manage meeting logistics and communication activities.
Project Management: Provide project management, process, and change leadership for GRPI-driven initiatives.
Team Supervision: Supervise a small team responsible for regulatory intelligence, communications, and operational support for GRPI.
Functional Leadership: Serve as a member of the GRPI Leadership Team (LT), contributing to strategic planning and decision-making processes.
Cross-Functional Collaboration: Work with cross-functional leaders and partners to advance policy initiatives, ensuring coordination and alignment across the organization.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: 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
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
This position is eligible to participate in the Company’s long-term incentive program.
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year