Job Description
Job Title: Principal Capability Professional for Registration Tracking xEVMPD 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 s upport 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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Tags
Permanent employment,