обновлено 6 часов назад
Director, Regulatory Data Office Leader (Regulatory Data Governance)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Regulatory Data Office Leader (Regulatory Data Governance): Leading global regulatory data governance, stewardship, and the Regulatory Data Hub to enable trusted data for analytics, decision-making, and regulatory transformation with an accent on data quality, standards, and cross-functional alignment. Focus on governing end-to-end Regulatory Information Management, supporting AI-enabled submission tooling, and building high-performing global data stewardship capabilities.
Location: Hybrid role in High Wycombe, Buckinghamshire, United Kingdom
Company
Johnson & Johnson develops innovative medicine and MedTech solutions across the healthcare spectrum.
What you will do
- Lead the global Regulatory Data Office and manage a team of data stewards and regulatory data experts.
- Own regulatory data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, stewardship program, standards, definitions, and business rules.
- Ensure regulatory data quality, integrity, accessibility, compliance, and responsible use across global data domains.
- Chair the cross-functional Regulatory Data Council and align central, regional, and local Global Regulatory Affairs needs.
- Provide business ownership for the Regulatory Data Hub and partner with IT, Data, Data Science and Artificial Intelligence, and R&D stakeholders.
- Enable Regulatory Information Management transformation, eLabeling, master data initiatives, and AI-supported submission excellence.
Requirements
- Bachelor’s degree in Science, Business, Computer Science or Technology, Regulatory Affairs, or an equivalent field; an advanced degree is preferred.
- At least 10 years of experience in a medium-to-large pharmaceutical, MedTech, or related healthcare environment.
- Regulatory Affairs knowledge and at least 2 years of people management experience.
- Experience owning data standards, quality, metadata, governance, stewardship, and issue resolution in a regulated environment.
- Strong data analysis, governance, project leadership, communication, negotiation, conflict-resolution, and stakeholder-influencing skills.
- Ability to operate in a global, matrix environment and build trust across cross-functional stakeholders.
Nice to have
- Hands-on knowledge of Veeva Vault RIM, IDMP, SPOR, xEVMPD, structured content, and regulatory systems.
- Experience leading data stewards or data governance in a regulated environment.
- Understanding of connections between regulatory processes, R&D, clinical, safety, and supply chain functions.
- Experience with digital transformation, agile value realization, and AI-enabled tooling.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and individual contribution.
- Collaborative work across Global Regulatory Affairs, R&D, IT, Data, Data Science and Artificial Intelligence, and enterprise teams.
- Opportunity to influence global regulatory data policy, standards, transformation, and decision enablement.
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