Regulatory Affairs Specialist
il y a 3 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.
Key Responsibilities:- Preparation and submission of Manufacturing License Application (MLA)
- Preparation and submission of Technical/Site Transfer Applications
- Preparation and submission of Marketing Authorisation Applications
- Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
- Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation
- Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
- Ensuring compliance with the regulations of the assigned Countries within European and International Regions
- Act as a liaison between the pharmaceutical company and the regulatory agencies
- Support internal requests for information
- 5-8 years of relevant experience in Regulatory Affairs Internationally
- Lifecycle maintenance experience
- Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling Applications
- Experience working with European Regulatory Authorities
- Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
- Good organizational skills and communication skills
- Ability to prioritize and deliver high-quality work
- Experience in people management/coordination is a plus
- Experience in promotional/non-promotional activities is a plus
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe 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...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe 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...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe 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.Key...
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, 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...
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Regulatory Affairs Specialist
il y a 1 jour
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, 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...
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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 join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesProvide regulatory support for all requests...
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, 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...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will play a crucial role in the development and implementation of our regulatory strategy for oncology projects.ResponsibilitiesProvide regulatory support for product development and registration,...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesRegulatory referral for all requests concerning products...
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Regulatory Affairs Specialist
il y a 1 mois
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a critical role in the implementation of our regulatory strategy for the development and registration of our oncology project.Key ResponsibilitiesProvide regulatory support for all...
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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 join our team at ProductLife Group. As a key member of our Regulatory Affairs Division, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesProvide regulatory support for all...
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About ProductLife...
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About ProductLife...
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Regulatory Affairs Specialist
il y a 1 mois
Courbevoie, Île-de-France ProductLife Group Temps pleinJob DescriptionWe 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...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review CoordinatorProductLife GroupWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key...
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Regulatory Affairs Specialist
il y a 4 heures
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesProvide regulatory referrals for all requests...
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Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. As a key member of our team, you will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About...
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Regulatory Affairs Specialist
il y a 1 mois
Courbevoie, Île-de-France ProductLife Group Temps pleinJob DescriptionWe 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...
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Regulatory Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About ProductLife...
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Regulatory Affairs Specialist
il y a 1 semaine
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review CoordinatorProductLife Group is seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams.About UsAt ProductLife Group, we are committed to delivering high-quality products and services to our clients. Our team of experts works closely together to ensure that...