Johnson & Johnson

Director, Regulatory Policy Research – Operations

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • District of Columbia • New Jersey • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $150,000 - $258,750 per year

Job Level

Lead

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsregulatory policyscientific researchproject managementchange leadershipdigital healthartificial intelligencehealthcare policyglobal regulatory environmentpeople management
Soft skills
communicationnegotiationstakeholder managementleadershipcross-functional collaborationstrategic planningteam engagementresource managementcapability buildingalignment