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- Tasks: Lead strategic transformation in regulatory tracking and enhance user experience.
- Company: Join Sanofi, a pioneering biopharma company focused on improving lives through science.
- Benefits: Competitive salary, extensive health benefits, and generous parental leave.
- Why this job: Make a real impact in the world of AI-powered research and regulatory innovation.
- Qualifications: 10+ years in regulatory operations with strong leadership and communication skills.
- Other info: Dynamic team environment with endless growth opportunities and a commitment to diversity.
The predicted salary is between 100000 - 140000 £ per year.
Location: Morristown, NJ/ Cambridge, MA
About the Job: Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. This role leads strategic transformation and innovation of Registration Tracking, Data Information Flow & Transactions Capability by driving compliance excellence, enhancing user experience, and promoting process consistency. You will define and drive cross-domain capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead the development of scalable and compliant solutions that support Sanofi regulatory strategy.
About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
- Strategic Capability Leadership: Define and drive cross-domain capability roadmaps with enterprise impact. Contribute to enterprise-level process architecture and governance, balancing standardization and innovation. Design and orchestrate complex workshop programs and testing strategies to support solution development and validation.
- Compliance & Operational Excellence: Develop enterprise compliance strategies and risk mitigation approaches. Represent the organization during critical audits and regulatory inspections related to Registration Tracking and Data Information Flow Capability. Drive transformational process improvements with significant ROI across end-to-end regulatory capabilities.
- System & Data Ownership: Serve as Business System Owner (BSO) for Veeva RIM, overseeing governance, documentation, and strategic alignment. Manage Registration Tracking backlog in JIRA and triage against Back to Standard Program. Lead resolution of Level 3 support issues and complex modeling challenges.
- Digital Transformation & Innovation: Evaluate and champion strategic technology investments in regulatory capability development, digital adoption, and AI. Analyze Veeva releases and roadmap critical features for future adoption. Contribute to structured data submission readiness (gradual IDMP implementation in multiple regions, such as PMS enrichment for Europe).
- Stakeholder Engagement & Enablement: Design enterprise change management frameworks and governance with Training and Communication teams. Facilitate Functional Lead forums and present best practices to Super Users. Develop talent and lead workstreams across Regulatory, Digital, and Data Governance.
Team-Specific Scope: Registration Tracking, Data Information Flow & Transactions Capability. As Business System Owner for Vault RIM RT: Focuses on the end-to-end flow of regulatory registration tracking data across various stages, departments, and systems. This includes managing Events, Activities, Regulatory Objectives, Workflows, Wizards, Impact Assessments, and Health Authority Interactions across global procedures and product types. Collaborates closely with the Process Owner (GRO) and Product Owner (Digital) for Registration Tracking and Data Transactions to ensure seamless alignment between system development and process operationalization, enabling effective Capability delivery.
About You:
- Experience: 10 years or more with demonstrated leadership in regulatory operations.
- Soft Skills: Expert communication and collaboration skills within a matrixed organization. Proven ability to lead, influence, and drive change in a fast-paced, cross-functional environment.
- Technical Skills: Expert knowledge of Veeva Vault RIM Registration Tracking, IDMP standards, and structured data submissions. Recognized authority in business process optimization in regulatory affairs. Expert understanding of capability-based planning, agile delivery, and digital product lifecycles. Strategic vision for digital tools, automation, and AI implementation.
- Education: BS/BA is required. Master’s degree or specialized training is preferred.
- Certifications: Advanced certifications with demonstrated application in LEAN, Agile, BPM or equivalent preferred.
- Languages: Fluent in English (spoken and written).
Why Choose Us: Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Principal Capability Professional for Registration Tracking xEVMPD in Cambridge employer: Sanofi
Contact Detail:
Sanofi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Capability Professional for Registration Tracking xEVMPD in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in your field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Tailor your answers to show how you fit into their mission and values. We want to see your passion!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. The more comfortable you are, the better you'll perform when it counts.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace Principal Capability Professional for Registration Tracking xEVMPD in Cambridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory operations and capability leadership. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Soft Skills: This role requires expert communication and collaboration skills. Use your application to demonstrate how you've successfully led teams or influenced change in a fast-paced environment. We love seeing real examples of your soft skills in action!
Highlight Technical Expertise: Don’t forget to mention your knowledge of Veeva Vault RIM and IDMP standards. We’re looking for someone who can hit the ground running, so make sure your technical skills shine through in your application.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at Sanofi!
How to prepare for a job interview at Sanofi
✨Know Your Stuff
Make sure you have a solid understanding of Veeva Vault RIM and IDMP standards. Brush up on your knowledge of regulatory operations and be ready to discuss how your experience aligns with the role's requirements.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership in cross-functional environments. Think about times when you've driven change or improved processes, and be ready to share these stories during the interview.
✨Communicate Clearly
Since expert communication is key for this role, practice articulating your thoughts clearly and concisely. Use the STAR method (Situation, Task, Action, Result) to structure your responses and keep them focused.
✨Engage with Questions
Prepare thoughtful questions that demonstrate your interest in Sanofi’s mission and the specific challenges of the role. Ask about their approach to digital transformation and how they envision the future of regulatory capabilities.
