Director CMC Regulatory Affairs

il y a 21 heures

GifsurYvette, Île-de-France Servier France Temps plein

Date de parution: 20 déc. 2025

Ville: GIF-SUR-YVETTE

Pays/Région: FR

Type de contrat: CDI

N° offre: 10219

Director CMC Regulatory Affairs (M/F)

Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « Engagés pour le progrès thérapeutique au bénéfice des patients ».

Aujourd'hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d'ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.

Nous ? passionnés de plus de 50 nationalités, portés par un esprit d'entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l'envie de prendre soin, d'oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.

Venez vivre et contribuez à faire vivre notre engagement #MovedByYou

Long Description

We are seeking a highly experienced Director CMC Regulatory
to drive the global strategy for small molecule assets within a fast-growing, innovation-driven environment. This is a high-impact, senior role with strategic visibility and the opportunity to shape a strong development pipeline.

This position reports directly to the Head of Small Molecule Development within Regulatory CMC.
Key Focus:
While early-stage exposure is valued,
deep expertise in late-stage development and preparation for global Marketing Authorisation submissions is essential.
We are looking for someone who has successfully guided assets through the final phases of development to approval.

Key Responsibilities:

  • Lead and own the global CMC Regulatory strategy for advanced-stage development assets
  • Drive high-quality, timely regulatory submissions and agency interactions
  • Partner closely with CMC technical functions, Quality Assurance, Supply Chain, and senior leadership
  • Ensure regulatory strategies enable accelerated development pathways and efficient product delivery

Profile:
We are seeking a
seasoned CMC Regulatory professional (15+ years)
with a
strong track record in late-stage development and global submissions
for small molecule assets. You bring strategic depth, scientific rigor, leadership maturity, and the ability to thrive in a dynamic, high-ambition environment.

If you bring proven late-stage CMC leadership and are motivated to shape impactful development programs, we would welcome a conversation.

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.

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