Regulatory Affairs Specialist Cmc
il y a 1 semaine
Dans la continuité du développement des activités du groupe, nous recherchons un(e) Chargé(e) d'affaires Réglementaires CMC sénior afin de renforcer les équipes.
Vous allez avoir des missions variées, travaillant sur la zone Europe pour l’enregistrement des nouveaux produits, ainsi que la gestion du cycle de vie du médicament.
Travaillant sur la partie CMC (Module 2.3 & 3) ainsi que le Module 1 pour les soumissions, vous allez avoir un rôle assez transverse que cela soit en interne (AQ, R&D, clinique, Réglementaire ) comme en externe (CRO, site de production ).
**Vos Missions**
- Participation à la stratégie Réglementaires du portefeuille de produit qui vous sera attribué.
- Coordonner les activités Réglementaires pour les nouveaux produits.
- Rédaction des modules 2.3 & 3 ainsi que la gestion des variations, renouvellement
- Coordonner la constitution des dossiers d’enregistrements ainsi que la soumission des dossiers d’AMM.
**Votre expérience**
- Issue d'une formation scientifique, vous avez une expérience d'au moins 5 ans sur la gestion du module 3: Rédaction, variation...
- Une expérience sur la zone Europe serait l’idéal (DCP, CP)
- Vous parlez français et Anglais.
Se lancer dans cette aventure, c'est rejoindre un groupe familial ou des opportunités en interne peuvent se présenter. C’est surtout un groupe où vous allez pouvoir vous exprimer, gagner en autonomie et développer vos compétences.
Je vous invite à me faire suivre votre CV afin d'échanger ensemble.
Type d'emploi : Temps plein, CDI
Salaire : 47 000,00€ à 52 000,00€ par an
Avantages:
- RTT
- Travail à domicile
Programmation:
- Du Lundi au Vendredi
Types de primes et de gratifications:
- 13ème Mois
- Prime annuelle
- Primes
Lieu du poste : Télétravail hybride (Lyon)
-
Regulatory Affairs Specialist for Medical Devices
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Skills Alliance Temps pleinThe Skills Alliance is partnering with a pioneering pharmaceutical & medical device company, harnessing the potential of ophthalmic medicine to deliver new treatments to patients with ocular diseases worldwide. As a key member of their global team, you will play a vital role in translating science into life-changing vision-saving treatments.This newly...
-
Regulatory Affairs Specialist
il y a 3 jours
Lyon, France Actalent Temps pleinWe have an exciting opportunity for you to join our growing Clinical Development team in Lyon, France, as a Regulatory Affairs Representative. This role is pivotal in supporting our development efforts and ensuring compliance with global regulatory standards.About the Role:In this newly created position, you will work under the supervision of the Clinical...
-
Regulatory Affairs Specialist F/m
Il y a 7 mois
Lyon, France bioMérieux sa Temps pleinA family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...
-
Senior Regulatory Affairs Manager EMEA
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Talents Solutions Temps pleinThe Talents Solutions company is seeking a highly skilled Senior Regulatory Affairs Manager EMEA to join its team. This is an excellent opportunity for a talented professional to take on a challenging role and contribute to the company's success.About the RoleThe Senior Regulatory Affairs Manager EMEA will be responsible for leading the regulatory affairs...
-
Cdi- Regulatory Affairs Specialist F/m
il y a 9 heures
Lyon, France bioMérieux sa Temps pleinbioMérieux S.A. **CDI- Regulatory Affairs Specialist F/M** A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45...
-
Intern Chemistry, Manufacturing
il y a 1 mois
Lyon 7e, France AUROBAC THERAPEUTICS Temps plein**PRESENTATION OF THE COMPANY** AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance...
-
Global Regulatory Affairs Cmc Manager
Il y a 4 mois
Lyon, France Merck Group Temps pleinExprimez votre talent avec nous ! Vous voulez explorer, franchir des obstacles, faire des découvertes ? Nous savons que vos projets sont ambitieux. Les nôtres aussi ! Dans le monde entier, nos collègues ont la passion de l’innovation scientifique et technologique qui enrichit les vies humaines grâce à nos solutions dans les domaines Healthcare, Life...
-
Cmc Manager
Il y a 6 mois
Lyon, France Amolyt Pharma Temps pleinDans le cadre de notre croissance et de notre développement, nous cherchons un(e) CMC manager. Cette personne aura la responsabilité de la conception, du développement, de la fabrication et du contrôle de la Substance Active et du Produit Fini pour soutenir les programmes de développement clinique d'Amolyt depuis le début du projet jusqu'à...
-
Regulatory Specialist
Il y a 7 mois
Lyon, France EastHORN Clinical Services Temps plein**Job summary**: As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in France. Reporting to **Clinical Operations Manager**, you will...
-
Business Develoment Manager
Il y a 6 mois
Lyon, France Staphyt Temps plein**About us**: We strengthen science together! Present in Europe, North Africa, South America, STAPHYT brings together more than 700 employees, of different nationalities and cultures. Rich in multiple profiles, a wide range of expertise is expressed in the Group, through our areas of activity which are agronomic experimentation, regulatory advice and...
-
Regulatory and Quality Manager
Il y a 7 mois
Lyon 7e, France Dr. Schär France Temps pleinIn our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär. The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent contract,...
-
Regulatory Specialist
Il y a 7 mois
Lyon, France Staphyt Temps plein**À propos de nous**: Staphyt’s Regulatory Affairs Division supports our clients in bringing plant protection, plant nutrition, biocide and REACH chemical products to the market. We help clients understand and address the EU & UK regulatory requirements for chemical or biological active substances and products. We support our clients throughout the full...
-
Regulatory - Label Specialist
Il y a 7 mois
Lyon, France FMC Corporation Temps plein**Are you an experienced Regulatory Specialist and a first background in a regulatory related role in chemical, pharma or plant protection industry?** In this role, you will help support our French Regulatory Team with respect for the core values of FMC as a company. - “You can look forward to joining a wonderful team with a very good team spirit. In...
-
Project Manager, Chemistry, Manufacturing
il y a 1 mois
Lyon 7e, France AUROBAC THERAPEUTICS Temps plein**PRESENTATION OF THE COMPANY** AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance...
-
Regulatory Team Leader
Il y a 6 mois
Lyon, France Staphyt Temps plein**About us**: We strengthen science together! Present in Europe, North Africa, South America, STAPHYT brings together more than 700 employees, of different nationalities and cultures. Rich in multiple profiles, a wide range of expertise is expressed in the Group, through our areas of activity which are agronomic experimentation, regulatory advice and...
-
Regulatory Manager
Il y a 7 mois
Lyon, France Staphyt Temps plein**About us**: Staphyt’s Regulatory Affairs Division supports our clients in bringing plant protection, plant nutrition, biocide and REACH chemical products to the market. We help clients understand and address the EU & UK regulatory requirements for chemical or biological active substances and products. We support our clients throughout the full...
-
Eu Regulatory Assistant and Systems Administrator
Il y a 7 mois
Lyon, France Thermo Fisher Scientific Temps pleinAs part of the Thermofisher Scientific's Pharmaceutical Service Group (PSG) European Regulatory Affairs (EU RA) team and reporting to a regional lead, you will discover meaningful work that makes a positive impact at a regional regulatory scale. Our focus is to contribute to our EU sites regulatory compliance and deliver “state of art” regulatory...
-
Global Medical Affairs Study Coordinator F/m
Il y a 6 mois
Lyon, France bioMérieux Temps pleinA family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
-
Fixed-term Contract 12 Months
il y a 7 jours
Lyon, France bioMérieux sa Temps pleinA family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large...
-
Responsable Affaires Réglementaires Bu Cdmo
Il y a 7 mois
Lyon, France Axplora Temps pleinAxplora’s mission is to be a trusted manufacturing partner to the world's leading pharmaceutical and biotechnology companies. Driven by passion, curiosity, and dedication of our highly skilled employees, we aim to make them being proud to collaborate with our customers to deliver cutting-edge products for the benefit of humankind. While accomplishing our...