Regulatory Affairs Specialist
il y a 4 semaines
About the Job
We are seeking an experienced Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for the development and registration of an oncology project. The successful candidate will be responsible for regulatory referrals, developing regulatory strategies, and contributing to the construction of global development plans.
Responsibilities
- Regulatory referrals for all requests concerning products under responsibility
- Develops regulatory strategies in collaboration with the Regulatory Affairs Divisions
- Contributes to the construction of global development plans
- Prepares and revises documents for authorization and follow-up of clinical studies
- Organizes and manages meetings with competent authorities
- Participates in due diligence for new partnerships
- Provides advice and opinions for product candidates
- Prepares regulatory analysis for product candidates
- Reviews licensing agreements
Requirements
- Pharmacist PhD or Masters in Pharmacy/Bachelor in Pharmacy
- 5 years of experience in Regulatory Affairs strategy/Drug development Plan, experience in oncology preferably
- Good scientific writing skills
- Fluent in English and French for daily communication
- Strong knowledge of RA early phase Drug development with track records in EU
- Team player with excellent organizational skills
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company, ProductLife Group. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.Responsibilities:Prepare and...
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-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).Responsibilities:Prepare and...
-
Regulatory Affairs Specialist
il y a 3 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistThe ProductLife Group is seeking a skilled Regulatory Affairs Specialist to coordinate and manage the Linguistic Review for Centralized products of one of our key clients.About usGroup 10 ResponsibilitiesCoordinate and manage the Labelling team in charge of the Linguistic Review for the products of one of our key...
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to coordinate and manage the Linguistic Review process for Centralized Procedure medicinal products. The ideal candidate will have a strong background in regulatory labelling procedures and excellent project coordination skills.Key Responsibilities:Coordinate and...
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a Regulatory Affairs Specialist to coordinate and manage the Linguistic Review process for Centralized Procedure medicinal products. The ideal candidate will have a strong understanding of regulatory labelling procedures and experience in Project Coordination/Management.Key Responsibilities:Coordinate and manage...
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for the development and registration of oncology projects. In this role, you will be responsible for regulatory referrals, developing regulatory strategies, and participating in the construction of global development...
-
Regulatory Affairs Team Lead Position
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Team Lead Role We are seeking a highly experienced Regulatory Affairs Team Lead to join our team at ProductLife Group. Responsibilities: Lead the regulatory affairs department in ensuring compliance with EU regulations. Manage a team of regulatory affairs specialists. Coordinate projects and ensure timely completion. Develop...
-
Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company, ProductLife Group. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.Key Responsibilities:Submission...
-
Regulatory Affairs Team Lead
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Team LeadWe are seeking a highly experienced Regulatory Affairs Team Lead to join our team at ProductLife Group.Key Responsibilities:Lead a team of regulatory affairs professionals in the European Union.Coordinate and manage regulatory projects, ensuring timely completion and compliance with regulatory requirements.Develop and implement...
-
Regulatory Affairs Expert
il y a 3 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join ProductLife Group. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.Key ResponsibilitiesSubmission and Approval Process:Preparation and...
-
Regulatory Affairs Expert
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinWe are seeking a highly skilled Regulatory Affairs specialist to support our pharmaceutical company's global regulatory compliance. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products worldwide.Key Responsibilities:Submission and Approval...
-
Regulatory Affairs Specialist: Implementing Oncology Projects
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are searching for a Senior Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for an oncology project. The successful candidate will be responsible for:Regulatory referrals for all requests concerning products under their responsibilityDeveloping the regulatory strategy for products in their portfolio...
-
Regulatory Affairs Team Lead
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Team Lead - European Union ExpertWe are seeking a highly experienced Regulatory Affairs Team Lead to join our team at ProductLife Group. The ideal candidate will have a strong background in regulatory affairs, with a minimum of 5 years of experience in a European Union regulatory affairs department.Key Responsibilities:Manage and...
-
Regulatory Affairs Specialist
il y a 3 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join ProductLife Group as a key member of our pharmaceutical team.About the RoleThe successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally. This involves...
-
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesDevelop and implement regulatory strategies for oncology products, evaluating local and global options.Contribute to the development and registration...
-
Regulatory Affairs Team Lead
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Team Lead Job DescriptionWe are seeking a highly skilled Regulatory Affairs Team Lead to join our team at ProductLife Group. As a key member of our regulatory affairs department, you will be responsible for leading a team of professionals and coordinating projects to ensure compliance with European Union regulations.Key...
-
Regulatory Affairs Officer
il y a 3 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review CoordinatorTo ensure and coordinate the Linguistic Review for the Centralized products of one of our key clients, we are seeking a Regulatory Affairs Officer / Linguistic Review Coordinator based in the EU to join our internal teams at ProductLife Group.About usProductLife Group is a leading company in the...
-
Apprenticeship Regulatory Reporting Specialist
il y a 1 mois
Courbevoie, Île-de-France HSBC Temps pleinJob DescriptionPlease note that this apprenticeship advertisement is only available in French. To view this job, change the language of the page to 'Français - France' using the language selector at the top of the page.RequirementsPlease note that this apprenticeship advertisement is only available in French. To view this job, change the language of the...
-
Scientific Affairs Associate for Medical Devices
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinProductLife Group is seeking a Scientific Affairs Associate for Medical Devices to strengthen our self-care medical device division. This role involves evaluating the efficacy and safety of health products in the European market.As a Scientific Affairs Associate, you will work closely with Senior Consultants in a small dynamic team, overseeing the entire...
-
Scientific Affairs Expert for Medical Devices
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinTo strengthen our medical device division, we are seeking a Scientific Affairs Expert for Medical Devices to evaluate the efficacy and safety of health products in the European market.This role involves working closely with Senior Consultants to oversee the life cycle of self-care medical device development, from conception to European registration.Self-care...