Regulatory Affairs Specialist 169
il y a 4 semaines
We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).
Group 10 Responsibilities:
Prepare and submit regulatory documents (INDs, NDAs, BLAs, MAAs, etc.) Ensure compliance with laws, regulations, and guidelines established by regulatory agencies and national regulatory authorities Collaborate with cross-functional teams during product development to ensure regulatory compliance from the early stages of research and development through to commercialization Oversee the development of product labeling and packaging materials to ensure compliance with regulatory requirements Manage regulatory aspects of clinical trials, including obtaining regulatory approvals, ensuring compliance with Good Clinical Practice (GCP) guidelines Monitor and report adverse events and other safety issues associated with pharmaceutical products to regulatory authorities as required by pharmacovigilance regulations Work closely with quality assurance and quality control teams to ensure that pharmaceutical products are manufactured, tested, and distributed in compliance with current Good Manufacturing Practice (cGMP) regulations Prepare for and participate in regulatory inspections and audits conducted by health authorities
Group 12 Experience:
Bachelor’s degree in pharmacy, life sciences, or a related field Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry Strong knowledge of regulatory requirements for drug development, approval, and marketing in the EU, and other major markets Excellent written and verbal communication skills in French and English, with the ability to effectively communicate complex regulatory requirements to cross-functional teams Proven ability to work independently and collaboratively in a fast-paced environment, with a strong attention to detail and accuracy Experience with regulatory submissions and interactions with health authorities is preferred Familiarity with pharmacovigilance regulations and adverse event reporting is a plus
-
Regulatory Affairs Specialist 192 193
il y a 2 semaines
Courbevoie, France ProductLife Group Temps pleinWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally). Group 10...
-
Senior Regulatory Affairs Specialist 479
il y a 4 semaines
Courbevoie, France ProductLife Group Temps pleinAbout the job In the frame of a new project, we are looking for an experienced Regulatory Affairs Specialist for the following tasks, in order to contribute to the implementation of the regulatory strategy for the development and registration of oncology project : About us Group 10 Responsibilities Regulatory referral for all...
-
Regulatory Affairs Team Lead
il y a 4 semaines
Courbevoie, France ProductLife Group Temps pleinRegulatory Affairs Team Lead - 780 We are looking for a RA TL who has people management experience and project coordination experience and minimum 5 years of experience in a regulatory affairs department (European Union) . Responsibilities: Experience with post-approval LCM for Module 1 is a plus Has an excellent organizational and...
-
Regulatory Affairs Officer
il y a 4 semaines
Courbevoie, France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/F - 025 To ensure and coordinate the Linguistic Review (LR) for the Centralized products of one of our key clients, we are urgently looking for a Regulatory Affairs Officer / Linguistic Review Coordinator based in the EU to join our internal teams. About us Group 10 Responsibilities...
-
Regulatory Risk Manager
il y a 1 mois
Courbevoie, France HSBC Temps plein-Job description At HSBC, we’re a trusted international organisation with a global customer base of around 39 million customers worldwide through a network that covers 62 countries and territories. In Europe, our ambition is to become the leading international wholesale bank and we need talent like you to help us meet our ambition. Whether you want a...
-
142 - Scientific Affairs Associate for Medical Devices
il y a 4 semaines
Courbevoie, France ProductLife Group Temps pleinTo strengthen our self-care medical device division, RNI – a PLG company, is seeking a Scientific Affairs Associate for Medical Devices with experience in evaluating the efficacy and safety of health products in the European market. In this role, you’ll work closely with Senior Consultants in a small dynamic team, overseeing the entire life cycle of...
-
Site Activation Specialist
il y a 4 semaines
Courbevoie, France IQVIA Temps pleinJob Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...
-
Cdd Regulatory Risk Manager
il y a 1 mois
Courbevoie, France HSBC Temps plein-Description de l'emploi **Le poste : Regulatory Risk Manager** Doté d’environ 3 000 milliards de dollars d’actifs et opérant dans 62 pays, le Groupe HSBC est l’un des plus grands groupes de services bancaires et financiers dans le monde. Nous sommes plus de 226 000 collaborateurs à accompagner chaque jour 39 millions de clients. En Europe, notre...
-
Aeronautical Specialist
il y a 1 semaine
Courbevoie, France TotalEnergies Temps pleinLogistics, Maintenance / Inspection / Technology, Operations/Exploitation - COURBEVOIE(PLD)-COUPOLE(FRA) - France - The - **Aviation Service **of - **TotalEnergies' OneTech entity** is mainly responsible for monitoring the Air Operators chartered for the Company (85% of flights are by helicopter, 15% by airplane + a drone activity currently under...
-
Clinical Operations Manager
il y a 5 jours
Courbevoie, France IQVIA Temps plein**Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Fluent in French and English.** **Essential Functions** - Oversee the execution of Site Activation...
-
Compensation & Benefits Specialist
il y a 4 semaines
Courbevoie, France ENGIE Temps pleinCompensation & Benefits Specialist (M/W)Human Resources About US (GEMS): ENGIE Global Energy Management & Sales (GEMS) provides energy supply solutions and risk management services to support its clients through their decarbonization journey, while optimizing ENGIE’s assets and contributing to value creation. ENGIE is a global reference in low-carbon...
-
Stage Droit Des Sociétés
il y a 4 semaines
Courbevoie, France Equans Temps plein**Offer ID**: - 52639**Métier**: - Support Functions / Regulatory/Public Affairs**Contract type**: - Internship**Country**: - France**Bouygues Energies & Services, Filiale d'Equans France, recherche son futur Stagiaire Droit des Sociétés (H/F).** **MISSIONS** Rattaché(e) à la Responsable Juridique Corporate, M&A, IP-IT du périmètre BYES, vos...
-
Sheq Partner
il y a 4 semaines
Courbevoie, France Azelis Temps pleinLe Groupe Azelis est l’un des leaders mondiaux de la fourniture de solutions innovantes dans l’industrie des produits chimiques de spécialité et des ingrédients alimentaires. Fondée en 2001, le Groupe Azelis s'est développé par une croissance organique comme par une croissance externe par le biais de diverses acquisitions. Nous sommes aujourd'hui...
-
Souscripteur Captives
il y a 4 semaines
Courbevoie, France AIG Temps pleinpublished in French and English / offre publiée en français et en anglaisQui sommes-nous ?American International Group, Inc. (AIG) est un des leaders mondiaux du secteur de l’assurance et des services financiers. Depuis plus de 100 ans, à travers le monde, nous proposons nos services à des milliers d’entreprises et à des millions de particuliers...