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Toxicologist - Impurities & Genotoxicity

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Ce poste représente une excellente opportunité de rejoindre une équipe dynamique et ambitieuse dédiée au soutien des programmes de développement de médicaments, depuis les phases précliniques jusqu'à l'obtention de l'autorisation de mise sur le marché.

Vous apporterez votre expertise en toxicologie sur les sujets liés à l'évaluation des impuretés, aux stratégies de gestion de la génotoxicité et à la détermination des limites d'exposition basées sur les risques sanitaires, au sein d'un environnement hautement collaboratif et réglementé.

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Pharmacokineticist Expert

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As an Operational PK/PD Expert, you will provide operational support to the Global Early Phases Clinical Expert and contribute to the development, registration, and commercialization of products across the portfolio.

Responsibilities include:

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Senior CMC Regulatory Technical Writer

posted by: spj_bot

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

Main Responsibilities:

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Sr. Director/Executive Director, Analytical Development

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Sr. Director/Executive Director, Analytical Development in the United States.

In this role, you will oversee the analytical development and commercial quality control functions for late-stage small molecule programs. You will play a key role in regulatory strategy and execution, ensuring robust analytical methods and high-quality data packages to support regulatory submissions. This position will collaborate cross-functionally with formulation, manufacturing, and quality teams, and interface closely with external partners. It is ideal for a scientific leader with deep technical expertise, a hands-on mindset, and a passion for impactful drug development. The environment is fast-paced, virtual, and mission-driven, requiring adaptability and a solutions-focused approach.

Accountabilities:

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