Director, Regulatory Data Office Leader

Director, Regulatory Data Office Leader

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.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Regulatory Data Office Leader. This position is a hybrid role and can be located in Horsham, PA; Raritan, NJ; or Titusville, NJ.

Global Regulatory Affairs (GRA) is seeking an experienced leader with deep regulatory domain expertise and a strong track record in data stewardship and governance. The Director, Regulatory Data Office Leader, will lead a global team of data stewards and oversee the Regulatory Data Hub (RDH), ensuring trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making as we build a world-class regulatory operations organization.

As the business owner of GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards, the Director will strengthen the quality, integrity, accessibility, and responsible use of GRA data. This highly collaborative and technically fluent leader will partner across R&D, Johnson & Johnson Technology (IT), Data, Data Science and Artificial Intelligence (DDSAI), and the enterprise to establish governance policies and standards and to embed trusted data into major transformation efforts. This will include end-to-end Regulatory Information Management (RIM) through the Unified Regulatory Platform (URP), R&D Digital Solutions Initiative (i.e. MDM), eLabeling and submission-excellence AI tooling. Regulatory Knowledge and Process Excellence (RKPE) operates through three integrated pillars - the Data Office, the Process Office, and Decision Enablement. As leader of the Data Office, the Director will be accountable not only for the performance of their own pillar but for actively creating synergy across all three, ensuring that trusted data, well-designed process, and decision enablement operates as one connected capability rather than three separate functions.

Principal Responsibilities:

• Data Governance and Stewardship
• Data Council and Framework Leadership
• Regulatory Data Hub - Business Ownership
• Transformation Enablement
• Leadership and People Management

Qualifications:

Education:

• A minimum of a Bachelor's degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent is required. Advanced degree Master's, Ph.D., PharmD) preferred.

Required:

• A minimum of 10 years of experience in a medium-to-large-scale Pharmaceutical, Medtech or related healthcare environment.
• Experience with a foundation of Regulatory Affairs knowledge.
• A minimum of 2 years of people management experience.
• Demonstrated experience serving as a data steward, lead data steward, data-domain governance lead, or equivalent business owner accountable for data standards, quality, metadata, ownership, and issue resolution in a regulated environment.
• Strong data analysis skills with the ability to translate data into information, and strategies into actionable plans.
• Strong understanding of the business aspects of data standards, data architecture/tools, and related governance.
• Knowledge of quality management and/or compliance principles within the drug development process.
• Experience leading projects and project teams.
• The ability to influence without authority and drive alignment in a global, matrix environment.
• The ability to build trust with cross-functional stakeholders.
• Excellent verbal and written communication skills.
• Strong networking, relationship-building, conflict-resolution, and negotiation skills.

Preferred:

• Hands-on knowledge of regulatory systems and standards (e.g., Veeva Vault RIM, IDMP, SPOR, xEVMPD) and structured content.
• Experience leading a team of data stewards, or leading data governance in a regulated environment.
• Understanding of how regulatory processes interconnect with R&D, clinical, safety, and supply chain.
• Experience supporting digital transformation, agile/rapid value-realization concepts, and AI-enabled tooling.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $150,000.00 - $258,750.00

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 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 10 daysVolunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits