R&D
Là où votre curiosité fait avancer les miracles de la science
Regulatory Strategy & Continuous Improvement - Platform Lead
En bref
Mettez votre curiosité au service d’une équipe où l’immunoscience de pointe rencontre l’innovation la plus avancée. Dans les domaines de l’oncologie, des maladies rares, de la neurologie et des vaccins, vous travaillerez à l’intersection entre la recherche en laboratoire et la découverte boostée par l’IA, tout en collaborant au-delà des frontières pour transformer des idées novatrices en impacts concrets. Que vous souhaitiez approfondir votre expertise scientifique ou évoluer en tant que leader, vous trouverez ici l’opportunité de le faire.
Job title: Regulatory Strategy & Continuous Improvement - Platform Lead
Location: Morristown, NJ
About the job
As Regulatory Strategy & Continuous Improvement - Platform Lead within our R&D team, you will lead multiple interconnected initiatives involving diverse stakeholders across the organization, orchestrating multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes. You will establish and maintain global responsibilities across GRA CMC & GRA Device departments, build and manage cross-functional governance structures to facilitate decision-making, identify synergies between parallel projects to leverage shared resources, and establish metrics and KPIs to track Progress and drive continuous improvement. Additionally, you will facilitate resolution of cross-project dependencies and conflicts, develop communication strategies to maintain visibility of project interdependencies, and synchronize change management processes across interconnected systems and procedures.
Your responsibilities will include driving transversal process-related activities and projects across the department, contributing to activities and ways of working harmonization/standardization, validating and updating worldwide CMC post-approval regulatory requirements databases, and representing GRA CMC and/or GRA Device departments in transversal working groups and for Quality & Performance topics. You will establish and promote best practices and sharing experiences, manage and facilitate information sharing across departments to ensure connectivity and alignment on critical CMC & Device topics, and contribute to inspection-readiness as applicable.
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.
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
Lead multiple interconnected and non-interconnected initiatives involving diverse stakeholders across the organization.
Orchestrate multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes.
Establish and maintain global responsibilities across GRA CMC & GRA Device departments, ensuring alignment between project objectives and broader organizational strategy.
Build and manage cross-functional governance structures to facilitate decision-making across interconnected projects
Identify synergies between parallel projects to leverage shared resources, eliminate redundancies, and maximize efficiency.
Establish metrics and KPIs to track progress across the project portfolio and drive continuous improvement.
Faciliate resolution of cross-project dependencies and conflicts through effective negotiation and prioritization.
Develop communication strategies to maintain visibility of project interdependencies and ensure alignment across stakeholder groups.
Synchronize change management processes across interconnected systems and procedures.
Cover a global responsibility across GRA CMC & GRA Device departments on activities within his/her scope
Drive/Manage transversal process related activities and or projects across the department and deliver documents (e.g. quality documents, Functional Best practice guides, slide kits…) helping the end-users to apply defined processes and ways of working.
Contribute to activities / WoW harmonization/standardization by taking the following action(s)
Optimize & improve efficiency of change control process, and of process for management of CMC post-approval commitments
Contribute to inspection-readiness as applicable
Validate, update & consolidate worldwide CMC post-approval regulatory requirements database for CMC Post-approval changes & RenewalsRepresent GRA CMC and/or GRA Device departments in transversal working groups dedicated to tools/systems optimization, e.g., IDMP
Represent GRA CMC and/or GRA Devices departments for Quality & Performance topics (e.g., quality documents creation/updates, KPIs…).
Establish and promote best practices and sharing experiences, e.g., manage/facilitate sharing of information across GRA CMC and/or GRA Device departments to ensure connectivity and/or to align on practices and critical CMC & Device topics.
About you
Education
Bachelor’s degree in a scientific discipline, or
Advanced degree (Masters, PhD) in a science or health field is desirable
Experience
Minimum 4 years of CMC and/or Devices regulatory experience. Additional 1-5 years of country/region-specific regulatory expertise is desirable.
Experience in project management is required.
Experience working for a Regulatory Authority, Quality Department, manufacturing site, project management/direction is preferred but not essential.
Soft skills
Experience working in a matrix environment and excellent people skills are required.
Previous experience working in a fast-paced environment on multiple project lines is highly desirable.
Ability to work transversally and to assume leadership of transversal topics/projects
Strong organization skills
Should demonstrate flexibility, proactivity, initiative, assertiveness & be able to communicate efficiently with various stakeholders internally and externally.
Potential to be able to mentor and train staff is desirable but not essential.
Technical skills
Knowledge of worldwide Health Authorities regulations, of key Health Authorities thinking (guidance/requirements/feedback), and regulatory trends.
Strong background in project management and understanding of drug development, manufacture, or testing.
Familiarity with combination (drug / device) products is preferred.
Proficient in MS Word, Excel, PowerPoint
Demonstrated ability to work successfully on global project teams.
Languages
Fluent in English both spoken and written
Why Choose Us
Bring the miracles of science to life alongside a supportive, futurefocused 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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
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.
Toujours Progresser. Découvrir l’Extraordinaire.
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, et autres facteurs objectifs. Les employés seront également éligibles aux programmes d'avantages sociaux de l'entreprise.
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Pourquoi nous rejoindre ?
- Élargissez vos horizons. Grandissez grâce à votre curiosité, avec le soutien nécessaire pour évoluer, apprendre et progresser dans une culture qui valorise le mentorat, la mobilité et le développement ambitieux.
- Accélérez les résultats grâce à la technologie. Exploitez la puissance de l'IA et de l'automatisation pour repousser les frontières de la science et réinventer ce qui est possible en matière de découverte de médicaments.
- Agissez grâce à une innovation inclusive. Contribuez à une science meilleure et à des résultats plus équitables en favorisant une recherche inclusive qui touche plus de personnes, de manière plus significative.
- Transformez les besoins des patients en avancées scientifiques. Faites naître des percées scientifiques qui partent des besoins des patients, et aboutissent à des traitements qui changent des vies.
Rencontrez Nils Libert, Associate Scientist
Faites la connaissance de Nils Libert, Associate Scientist en Belgique, où il joue un rôle clé dans l’avancement de recherches de pointe. Découvrez comment son travail contribue à faire progresser l’innovation, à ouvrir de nouvelles perspectives scientifiques et à développer des traitements qui changent la vie des patients partout dans le monde.
"Chez Sanofi, nous construisons un véritable accélérateur de R&D alimenté par la science la plus performante, l’innovation digitale et la volonté de transformer la vie des patients dans le monde entier."
Houman Ashrafian
Vice-Président Exécutif & Responsable R&D
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Nos domaines de recherche prioritaires
Découvrez comment nous réinventons l’avenir de la médecine grâce à l'immunologie, ouvrant la voie à des avancées transversales audacieuses, encore inimaginables il y a dix ans.
Rencontrez nos équipes dans les laboratoires
Poussez les portes de nos labos et écoutez les témoignages scientifiques qui transforment une science de pointe en impact réel, guidés par la curiosité, la collaboration et le sens du collectif.
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