Junior Regulatory Affairs Specialist
il y a 2 semaines
Junior Regulatory Affairs Specialist (M/F)- CDD 12 months
Medincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team which main mission is to ensure that all products meet the necessary legal and regulatory requirements, facilitating their approval and market entry.
The successful candidate will be responsible for managing and coordinating regulatory submissions, ensuring compliance with industry standards, and maintaining up-to-date knowledge of regulatory requirements.
Missions
- Coordinate with cross-functional teams to gather necessary information for regulatory submissions (meeting requests, rehearsals, briefing book preparations, and meeting minutes).
- Oversee the preparation and maintenance of regulatory submissions and files for the US and EU (IND/CTA).
- Perform Quality Control (QC) of regulatory documents.
- Manage electronic submissions to FDA, EMA, and MHRA in the appropriate format.
- Manage and archive documents while maintaining internal regulatory databases to ensure accurate and up-to-date records.
- Stay up to date with FDA, EMA, and MHRA regulations, guidance documents, and ICH guidelines.
- Provide regulatory support during inspections and audits.
- Perform quality control (QC) of documents to ensure accuracy and compliance.
Profile
- Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology).
- Minimum of 2 year of experience in regulatory operations within the pharmaceutical or biotechnology industry.
- In-depth knowledge of regulatory submission processes and requirements.
- French and Fluent in English, spoken and written ability to attend meetings and write clear reports.
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- Proficiency in electronic document management systems and regulatory information management systems.
- Experience with global regulatory submissions (US, UE & UK)
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Strong problem-solving skills and attention to detail.
Competitive package composed of:
Competitive Base Salary
Bonus and Profit Sharing
Lunch vouchers (€9 per day, 60% paid by the company)
Sport and yoga sessions onsite available 4 times a week
Monthly socializing events
Very flexible working hours and home office policy
Medincell is an equal opportunity employer welcoming applications from all individuals, including those with disabilities.
-
internship: junior
il y a 2 semaines
Montpellier, Occitanie, France Medincell Temps pleinJunior Regulatory Affairs Specialist (M/F)- CDD 12 months Medincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their...
-
internship: junior
il y a 1 jour
Montpellier, Occitanie, France Medincell Temps pleinJunior Regulatory Affairs Specialist (M/F)- CDD 12 months Medincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their...
-
Quality Engineer Foot and Ankle
il y a 7 heures
Greater Lyon Area, France CONMED Foot & Ankle Temps pleinCONMED is a global medical technology company that specializes in the development and manufacturing of surgical devices and equipment. With a mission to empower healthcare professionals to deliver exceptional patient care, CONMED is dedicated to innovation, quality, and excellence in all aspects of our operations.As a Quality Engineer you will be part of the...
-
Translational Pharmacokinetics Scientist
il y a 3 semaines
Montpellier, Occitanie, France Medincell Temps pleinMedincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one...
-
Translational Pharmacokinetics Scientist
il y a 1 semaine
Montpellier, Occitanie, France Medincell Temps pleinMedincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one...
-
Administrateur système/Administratrice système
il y a 4 semaines
Greater Grenoble Metropolitan Area, France Grafton Recruitment Temps pleinÀ propos de nous : Fort de plus de 40 années d'expérience en Europe, Grafton est spécialisé dans le recrutement de professionnels qualifiés que ce soit pour des besoins uniques comme pour des projets volumiques.En France, Grafton rassemble une centaine de professionnels du recrutement répartis au sein d'un réseau de 14 bureaux. Ils délèguent...
-
Translational PKPD Lead
il y a 1 semaine
Montpellier, Occitanie, France Barrington James Temps pleinTranslational Pharmacokinetics LeadOverviewAn exciting opportunity for an experienced PK modeler to join my clients expanding team. I am currently working with a commercial-stage global pharmaceutical company, with assets across multiple therapeutic areas. The team are based onsite in the South of France are looking for an experienced Translational PK...
-
Translational PKPD Lead
il y a 1 jour
Montpellier, Occitanie, France Barrington James Temps pleinTranslational Pharmacokinetics Lead Overview An exciting opportunity for an experienced PK modeler to join my clients expanding team. I am currently working with a commercial-stage global pharmaceutical company, with assets across multiple therapeutic areas. The team are based onsite in the South of France are looking for an experienced Translational...
-
Clinical Specialist
il y a 24 heures
Montpellier, Occitanie, France Bausch & Lomb Temps pleinBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing...
-
Leader scientifique H/F
il y a 4 jours
Montpellier, Occitanie, France Barrington James Temps pleinI am working with a very exciting client, who's Analytical team are looking for a Lead Chromatography Specialist to join their expanding group and take the reigns as a Senior member who can lead from the front with the design of experiments, data generation and interpretation, pre-validation, and implementation of analytical methods using UPLC/HPLC systems...
-
Leader scientifique H/F
il y a 4 jours
Montpellier, Occitanie, France Barrington James Temps pleinI am working with a very exciting client, who's Analytical team are looking for a Lead Chromatography Specialist to join their expanding group and take the reigns as a Senior member who can lead from the front with the design of experiments, data generation and interpretation, pre-validation, and implementation of analytical methods using UPLC/HPLC systems...
-
Lead/Senior Analytical Scientist Chromatography
il y a 20 heures
Montpellier, Occitanie, France Barrington James Temps pleinJob Description:I am working with a very exciting client, who's Analytical team are looking for a Lead Chromatography Specialist to join their expanding group and take the reigns as a Senior member who can lead from the front with the design of experiments, data generation and interpretation, pre-validation, and implementation of analytical methods using...
-
Senior Mechanical Engineer
il y a 7 jours
Montpellier, Occitanie, France Altrad Temps pleinJob descriptionSenior Mechanical EngineerGlasgow, Scotland Summary of the RoleThe nuclear defence sector in the UK is vital for maintaining national security and strategic stability. It offers dynamic and challenging career opportunities for individuals committed to contributing to the country's defence and security. The sector seeks talented professionals...
-
Civil & Structural Engineer
il y a 16 heures
Montpellier, Occitanie, France Altrad Temps pleinJob descriptionCivil Structural EngineerGlasgow, Scotland Summary of the RoleThe nuclear defence sector in the UK is vital for maintaining national security and strategic stability. It offers dynamic and challenging career opportunities for individuals committed to contributing to the country's defence and security. The sector seeks talented professionals...
-
Lead/Senior Analytical Scientist Chromatography
il y a 4 jours
Montpellier, Occitanie, France Barrington James Temps pleinJob Description: I am working with a very exciting client, who's Analytical team are looking for a Lead Chromatography Specialist to join their expanding group and take the reigns as a Senior member who can lead from the front with the design of experiments, data generation and interpretation, pre-validation, and implementation of analytical methods using...
-
Lead/Senior Analytical Scientist Chromatography
il y a 4 jours
Montpellier, Occitanie, France Barrington James Temps pleinJob Description: I am working with a very exciting client, who's Analytical team are looking for a Lead Chromatography Specialist to join their expanding group and take the reigns as a Senior member who can lead from the front with the design of experiments, data generation and interpretation, pre-validation, and implementation of analytical methods using...
-
Sales Development Representative
il y a 8 heures
Greater Paris Metropolitan Region, France Rocket4Sales Temps pleinRocket4sales accompagne un nom très connu du SaaS, Editeur de logiciel spécialiste de la gestion de paie et RH conçue spécifiquement pour les TPE et PME.Forte de son succès, l'entreprise cherche à renforcer sa Team Sales.Nous cherchons un profil junior, sortant d'école de commerce pour un poste de Sales Development Représentative / SDR, en CDI pour...
-
ingénieur informatique DEVOPS
il y a 20 heures
Montpellier, Occitanie, France CONSULT IT Temps pleinNous recherchons un(e) Ingénieur(e) DEVOPS / Spécialiste MLOps pour rejoindre notre équipe dans le cadre d?une mission stratégique visant à optimiser et déployer des solutions Data au sein du Groupe. Les principales responsabilités incluent :Mise en ?uvre opérationnelle et technique des produits Data :Industrialiser et automatiser le déploiement de...
-
Mechanical Engineer
il y a 24 heures
Montpellier, Occitanie, France Altrad Temps pleinJob descriptionMechanical EngineerGlasgow, Scotland. Summary of the RoleThe nuclear defence sector in the UK is vital for maintaining national security and strategic stability. It offers dynamic and challenging career opportunities for individuals committed to contributing to the country's defence and security. The sector seeks talented professionals...
-
Responsable de Bureau H/F
il y a 2 semaines
Montpellier, Occitanie, France Grafton Recruitment Temps pleinGrafton Recruitment, spécialiste de l'intérim et du recrutement de profils juniors à professionnels confirmés, recherche pour l'un de ses clients basé à Montpellier un Gestionnaire Back Office Bancaire H/F en intérim. Type de poste : Intérim Date de prise de poste : 17 mars Salaire : 12,06€ /heure + 13ème mois Préparation administrative des...
