Passer au contenu principal
Deux femmes en blouse blanche regardent ensemble un écran d’ordinateur

Global Regulatory Strategist

Amsterdam, Pays-Bas
Gentilly, France Permanent Posté le   Jun. 06, 2025 Expire le   Jun. 30, 2025
Postulez maintenant

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Duties & Responsibilities

  • Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.
  • Contributes to the GRT for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the Target Product Profile (TPP), business planning, governance, and committees. May be requested to lead GRT meetings.
  • Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products.
  • May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
  • Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
  • May lead HA meetings and preparations as designated.
  • Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable.
  • Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
  • Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross functional team and/or alliance partners where relevant.

About you

  • BS/BA degree in a relevant scientific discipline required.  Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred
  • At least 6 years of prior pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
  • Experience with clinical development of drugs and/or innovative biologics products. Gene and cell therapies preferred. 
  • Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred
  • Experience on multidisciplinary matrixed project teams (e.g. clinical study
  • team) preferred
  • Project leadership experience preferred

#LI-EUR #LI-Hybrid

Toujours progresser. Découvrir l’extraordinaire.

Le progrès ne se fait pas tout seul, ce sont les gens qui le construisent : des gens d'horizons différents, dans des lieux différents, dans des rôles différents, mais tous réunis par une même motivation : la volonté de rendre l’impossible possible. Et si vous rejoigniez cet élan ? Afin de poursuivre le changement, adopter de nouvelles idées et explorer toutes les opportunités que nous avons à offrir. Ensemble, continuons de progresser. Et partons à la découverte de l'extraordinaire.

Chez Sanofi, nous croyons en l’égalité des chances pour tout le monde, indépendamment de l’origine, de la couleur de peau, des croyances, du genre, de l'orientation sexuelle, de l'âge, de la citoyenneté, de l'état civil, du handicap ou de l’identité de genre.

Regardez « Une journée type chez Sanofi » et découvrez nos initiatives en matière de diversité, d'équité et d'inclusion sur sanofi.com

Postulez maintenant
Notre processus de recrutement
Préparer votre CV et postuler
Se préparer à l’entretien

  • Vous n'avez pas encore consulté aucune d'offres d'emploi

  • Vous n'avez pas encore enregistré d'offres d'emploi.

Femme à vélo devant la Tour Eiffel

Carrières Sanofi en France

En France, 20 000 personnes, sur 28 sites partagent un objectif commun : fournir des médicaments et des vaccins aux personnes qui en ont le plus besoin. Dès le premier jour, les projets proposés détermineront votre carrière. Chercheur ou spécialiste du marketing, vous progresserez à l’aide des outils et ressources proposés. Développez vos compétences au sein d’équipes inclusives pour avoir un impact positif sur des millions de personnes dans le monde.

Explorez Sanofi France
Illustration of map pins on globe

En savoir plus
sur ce site

Plan du site

Un monde de possibilités

Rejoignez notre communauté
de talents

Que pourrions-nous accomplir ensemble ? Chaque Sanofien travaille sur des projets qui ont un véritable impact sur la vie des gens.

Inscrivez-vous dès aujourd'hui et découvrez nos dernières opportunités dès qu'elles seront disponibles.

Inscrivez-vous aujourd'hui