At a Glance
- Tasks: Lead global data governance for Regulatory Affairs and drive data quality and analytics.
- Company: Join a leading pharmaceutical company focused on regulatory transformation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative global team with excellent career advancement opportunities.
- Why this job: Make a strategic impact in a data-driven environment while shaping the future of regulatory data.
- Qualifications: Bachelor's degree required; 10+ years in healthcare with strong data governance experience.
The predicted salary is between 60750 - 74250 £ per year.
As Director, Regulatory Data Office Leader, you will guide global data governance for Regulatory Affairs, shaping trusted regulatory data to enable analytics and informed decisions. You’ll lead a distributed team and own the Regulatory Data Hub and governance framework, partnering with R&D, IT, and DDSAI to drive end-to-end RIM transformations. You’ll advance data quality, standards, and stewardship to support AI-enabled tooling and submission excellence. This role offers strategic impact in a data-driven, regulatory transformation environment.
Responsibilities
- Lead data governance and stewardship for GRA data, ensuring quality, ownership, access, and decision rights across systems.
- Chair the Regulatory Data Council and align GRA data domains with enterprise data governance.
- Own the Regulatory Data Hub (RDH) and ensure data is curated for decision-making and alignment with data products.
- Collaborate with IT (JJT) and DDSAI to enable consistent data management across business use cases.
- Shape strategic input for tools and processes to collect, share, submit, and track regulatory data; support URP, MDM/DSI, eLabeling, and AI tooling.
- Drive end-to-end RIM transformation and steward data governance from design to adoption.
- Provide leadership and development for a global team of data stewards; set priorities and performance objectives.
- Coordinate with Process Office and Decision Enablement to connect data standards to process design and decision-ready insights.
Key requirements
- Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs (required); Master’s/PhD preferred.
- Minimum 10 years of experience in a pharmaceutical/Medtech or related healthcare environment.
- At least 2 years of people management experience.
- Experience as data steward or data governance lead in a regulated environment.
- Strong data analysis skills and ability to translate data into actionable plans.
- Deep knowledge of data standards, data architecture/tools, and governance.
- Understanding of quality management and compliance in drug development.
- Experience leading projects and cross-functional collaboration in a global, matrix setting.
- Excellent communication, networking, relationship-building, conflict-resolution, and negotiation skills.
- Ability to influence without authority and drive alignment across functions.
Director, Regulatory Data Office Leader employer: Johnson & Johnson
At Johnson & Johnson, we pride ourselves on being an exceptional employer, fostering a culture of inclusivity and respect for diversity. Our Leeds location offers employees the opportunity to work at the forefront of healthcare innovation, with access to comprehensive training and development programmes that support personal and professional growth. Join us to be part of a team that is dedicated to making a profound impact on health for humanity while enjoying a collaborative and supportive work environment.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Data Office Leader
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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 Johnson & Johnson!
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 Johnson & Johnson 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 Johnson & Johnson!
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 Johnson & Johnson, 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 Johnson & Johnson
✨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 Johnson & Johnson 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 Johnson & Johnson’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.
