At a Glance
- Tasks: Lead a global team to ensure high-quality regulatory data for informed decision-making.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and patient-focused solutions.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on diversity and inclusion.
- Why this job: Make a real impact on healthcare by driving data governance and transformation.
- Qualifications: 10+ years in healthcare with strong leadership and data stewardship experience required.
The predicted salary is between 51750 - 63250 £ per year.
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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: People Leader
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
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.
This position is a hybrid role and will be located in High Wycombe, United Kingdom. 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.
Principal Responsibilities:
- Data Governance and Stewardship: Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data.
- Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making.
- Establish and maintain data governance policy, standards, definitions, and business rules for regulatory data across systems, in close alignment with R&D, Pharma, and cross-sector initiatives.
- Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR).
- Enable Data Stewards and Domain Owners to establish and monitor regulatory data quality metrics, lead root-cause analysis, prioritize remediation, and measure sustained improvement across regulatory data domains.
Data Council and Framework Leadership: Operate and chair the cross-functional Regulatory Data Council, governing access to and ingestion of regulatory data and harmonizing with enterprise data governance frameworks. Reconcile central, regional, and local GRA business needs while ensuring overall efficiency and quality.
Regulatory Data Hub - Business Ownership:
- Provide day-to-day business functional ownership of the Regulatory Data Hub (RDH), turning fragmented regulatory data into trusted, curated regulatory data for decision making.
- Provide governance and stewardship through the Regulatory Data Council to align GRA data domains with data products.
- Collaborate with JJT (IT) and DDSAI to enable consistent management and effective use of regulatory data across a range of business use cases.
- Provide strategic input to current and future tools and processes used to collect, share, submit, and track regulatory data, ensuring related business support and services are provided to the GRA community.
- Anticipate business needs and evolve data and technology capabilities ahead of industry trends.
Transformation Enablement:
- Provide strategic leadership to engage and support end-to-end RIM transformation through the Unified Regulatory Platform (URP), ensuring data governance, quality, and stewardship requirements are embedded from design through adoption.
- Partner on submission-excellence and next-generation submission efforts, supporting the responsible adoption of AI, automation, and simulation capabilities with trusted, well-governed data as the foundation.
- GRA leader and enabler of success across programs representing a broader transformation landscape that will require thoughtful strategy, silo elimination, and alignment across R&D and the enterprise (e.g. eLabeling, MDM/DSI).
- Stay attuned to the impact of global initiatives and direct regulatory contributions to the implementation strategy for globally developed regulatory authority programs.
Leadership and People Management:
- Lead and develop a global team of data stewards and experts through direct and indirect reporting relationships.
- Establish clear data domain accountabilities and priorities, create individual and team capability development plans, and set measurable performance expectations aligned with business needs.
- Provide customer-focused leadership that empowers, promotes, and motivates high-performing teams, drives innovation, and fosters collaboration and diversity to deliver results.
- Contribute expertise to internal and external initiatives that influence evolving policy and requirements impacting regulatory data capabilities.
- Partner deliberately with the Process Office and Decision Enablement leads to connect data standards to process design and to translate governed data into decision-ready insight, jointly setting shared priorities, resolving interdependencies, and presenting an integrated RKPE agenda to stakeholders.
Qualifications:
- Education: A minimum of a Bachelors degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent is required. Advanced degree (Masters, 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.
Director,Regulatory Data Office Leader employer: J&J Family of Companies
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment that fosters personal and professional growth. Our commitment to diversity, equity, and inclusion ensures that every employee feels valued and empowered to reach their full potential, while our comprehensive benefits package supports both physical and mental wellbeing. Located in North London and Hertfordshire, you will be part of a pioneering team at the forefront of healthcare innovation, making a meaningful impact on lives around the world.
StudySmarter Expert Advice🤫
We think this is how you could land Director,Regulatory Data Office Leader
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like J&J Family of Companies. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like J&J Family of Companies.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like J&J Family of Companies. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what J&J Family of Companies is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director,Regulatory Data Office Leader
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at J&J Family of Companies!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show J&J Family of Companies that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at J&J Family of Companies!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At J&J Family of Companies, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at J&J Family of Companies
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at J&J Family of Companies that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with J&J Family of Companies’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
