PharmD – Technical and Regulatory Project Manager F / M

Aixial Group; Auvergne-Rhône-Alpes; Sur place; EUR 55 000 - 70 000; Plein temps

Résumé du poste

Une organisation de recherche clinique internationale recherche un Pharmacien – Responsable de Projets Techniques et Réglementaires. Le candidat idéal dispose d'une formation en pharmacie, ainsi que de plus de 5 ans d'expérience en affaires réglementaires CMC. Dans ce rôle, vous gérerez des projets clés et contribuerez à des dossiers de renouvellement, tout en interagissant avec des autorités sanitaires. Un environnement dynamique et une vraie possibilité de croissance vous attendent.

Prestations

Environnement de travail inclusif

Soutien à la carrière

Possibilité d'évoluer dans des projets d'avant-garde

Qualifications

• Au moins 5 ans d'expérience en affaires réglementaires CMC dans l'industrie pharmaceutique.
• Expérience prouvée en rédaction CMC (Module 3).
• Compétences organisationnelles et autonomie.

Responsabilités

• Gérer les changements de nom des fichiers de produits.
• Analyser les exigences réglementaires pour chaque fichier.
• Participer au développement de la stratégie réglementaire CMC.
• Préparer et rédiger des dossiers de renouvellement.

Connaissances

Compétences en affaires réglementaires CMC

Anglais courant

Organisation

Communication

Formation

Diplôme de pharmacie, spécialisation en affaires réglementaires

Description du poste

Overview

PharmD – Technical and Regulatory Project Manager F / M

Are you passionate about the life sciences and clinical research? Do you want to grow in a dynamic, international, and collaborative environment where your expertise has a direct impact on the lives of millions of people? Join Aixial Group and help shape the future of clinical research!

AIXIAL Group is looking for its next talent as a Pharmacist – Technical and Regulatory Project Manager (M / F). Your responsibilities will include (non-exhaustive list):

Responsibilities

• Managing the name changes of product files such as company names.
• Analyzing regulatory requirements for each file / product.
• Participating in the development of the CMC (Chemistry, Manufacturing, and Controls) regulatory strategy.
• Implementing CMC regulatory watch / monitoring.
• Preparing and drafting renewal dossiers (Marketing Authorization renewals).
• Writing the regulatory part of Module 3 in CTD (Common Technical Document) format for Marketing Authorization dossiers.
• Verifying the consistency of the entire dossier and preparing the Marketing Authorization application.
• Interacting with health authorities or others during ongoing procedures.
• Collecting the necessary data and documents.

Required Profile and Skills

• You hold a Pharmacy degree, with a specialization in Regulatory Affairs (Master’s level) or equivalent.
• You have at least 5 years of experience in CMC Regulatory Affairs within the pharmaceutical industry, CROs, and / or laboratories.
• Are you looking for experience in pre-market or post-market?
• You have proven experience and strong writing skills in CMC (Module 3).
• You are fluent in both written and spoken English and bilingual in French.
• You demonstrate strong organizational skills and autonomy.
• You have excellent communication skills.

Who We Are

We are one of the world’s leading Contract Research Organizations (CROs), with the commitment, expertise, and flexibility necessary to successfully conduct clinical studies.

We work with pharmaceutical, biotechnology, cosmetic companies, and many others, providing innovative and adaptable solutions.

We operate in 10 countries across 3 continents, bringing together more than 1,000 talented professionals dedicated to actively advancing clinical research.

We have been part of the ALTEN Group since 2014 and continuously explore new opportunities to grow our business worldwide.

Joining Aixial Group means

• Being at the forefront of clinical research : You will work on cutting-edge projects where your expertise will be fully utilized and have a real impact on the lives of millions.
• Continuously developing your career and skills : Our employees are at the heart of our priorities. At Aixial Group, you will be coached and supported throughout your journey to help you grow both professionally and personally.
• Working in an environment where equality, diversity, and inclusion are integral to our commitment : Our goal is to promote a workplace based on dignity and respect, where individual differences are recognized and valued, and where every employee can give their best. Gender equality is central to Aixial Group’s development strategy.