Emplois actuels liés à Regulatory Affairs Specialist - Paris - Nanobiotix
-
Regulatory Affairs Specialist
il y a 5 jours
Paris, Île-de-France ProductLife Group Temps pleinWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. The ideal candidate will have a strong background in regulatory affairs and experience in managing product registrations in Asia and Sub-Saharan Africa.The Regulatory Affairs Specialist will be responsible for:Developing and implementing regulatory strategies...
-
Regulatory Affairs Specialist
il y a 1 semaine
Paris, Île-de-France Indegene Temps pleinAbout the RoleIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for providing expert guidance on regulatory matters related to medical devices in the France market.Key ResponsibilitiesProvide guidance on standards pertaining to advertising and promotion of medical...
-
Regulatory Affairs Specialist
il y a 7 jours
Paris, Île-de-France Indegene Temps pleinJob DescriptionAt Indegene, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Consultant, you will play a crucial role in providing expert regulatory advice to our team and ensuring that our clients' projects meet the required standards.Key Responsibilities:Provide guidance on standards pertaining to...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France ProductLife Group Temps pleinWe are looking for a Regulatory Affairs Specialist to lead and optimize our regulatory strategies across diverse markets in Asia and Sub-Saharan Africa.Key Responsibilities:Develop and execute regulatory frameworks for product approvals and ongoing complianceProvide guidance to local authorities to ensure adherence to regulatory standardsOversee portfolio...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France ProductLife Group Temps pleinWe are looking for a Regulatory Affairs Specialist to manage and improve our regulatory portfolio across Asia and Sub-Saharan Africa.Key Responsibilities:Develop and execute regulatory strategies for product approvals and ongoing complianceProvide guidance to local authorities to ensure adherence to regulationsEnsure portfolio compliance and maintain...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France ProductLife Group Temps pleinWe are looking for a Regulatory Affairs Specialist to manage and optimize our regulatory initiatives across Asia and Sub-Saharan Africa.Key Responsibilities:Develop and execute regulatory strategies for product approval and ongoing complianceProvide guidance to local authorities to ensure adherence to regulatory standardsEnsure portfolio compliance and...
-
Regulatory Affairs Specialist
il y a 4 jours
Paris, Île-de-France ProductLife Group Temps pleinJob SummaryProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Paris region. As a key member of our project team, you will be responsible for ensuring the delivery of regulatory activities performed onsite.About the RoleUnder the responsibility of the regulatory coordinator, you will work closely with subsidiaries,...
-
Regulatory Affairs Specialist
il y a 7 jours
Paris, Île-de-France Planet Pharma Temps pleinJob DescriptionRole Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Planet Pharma. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites.Key Responsibilities:Regulatory Compliance:...
-
Regulatory Affairs Specialist
il y a 7 jours
Paris, Île-de-France ProductLife Group Temps pleinJob SummaryProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Paris region. As a key member of our project team, you will be responsible for ensuring the delivery of regulatory activities performed onsite.About the RoleUnder the responsibility of the regulatory coordinator, you will work in close collaboration...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France Internetwork Expert Temps pleinABOUT THE POSITION Seeking a fulfilling career? Join Internetwork Expert. At Internetwork Expert, our team members challenge themselves to innovate and explore new possibilities, strive to exceed their objectives, and enhance their personal and professional growth. We refer to this as a dynamic career at Internetwork Expert, providing a comprehensive...
-
Regulatory Affairs Specialist
il y a 5 jours
Paris, Île-de-France ProductLife Group Temps pleinAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in France.Key ResponsibilitiesPrepare and submit registration files and responses to regulatory authorities.Coordinate the preparation of clinical study authorization request files.Develop and submit consultation requests with regulatory...
-
Regulatory Affairs Specialist 362
Il y a 4 mois
Paris, France ProductLife Group Temps pleinRegulatory Affairs Specialist 362 In the frame of a project for one of our Top Clients, we are seeking for a Regulatory Affairs Specialist ( pharmacist ) responsible for ensuring the delivery of regulatory activities performed onsite in Paris region. About us Group 10 Responsibilities Under the responsibility of the regulatory coordinator...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France Meet Recruitment Limited Temps pleinRole OverviewThe Regulatory Affairs Specialist will be responsible for the meticulous preparation of submissions related to license modifications, notifications, and renewals, adhering to stringent deadlines.Key ResponsibilitiesMonitor and establish timelines for the approval processes of license variations, notifications, and renewals.Prepare essential...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France Norgine Temps pleinABOUT THE POSITIONAre you ready to embark on a fulfilling career path? At Norgine, we encourage our team members to embrace innovation, pursue excellence, and foster personal growth.We believe in a comprehensive career experience that empowers you to bring your unique strengths to the forefront. Whether you are passionate about making a positive impact,...
-
Regulatory Affairs Specialist
il y a 2 jours
Paris, Île-de-France Indegene Temps pleinRegulatory Affairs ConsultantIndegene is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory requirements for promotional and scientific communication materials for medical devices in France and other global regions.Key...
-
Pharmacist Regulatory Affairs Specialist
il y a 7 jours
Paris, Île-de-France AIXIAL GROUP Temps pleinJob DescriptionAIXIAL GROUP is seeking a highly skilled Pharmacist Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing regulatory strategies for our oncology products.Key Responsibilities:Regulatory Strategy Development: Collaborate with cross-functional...
-
Regulatory Affairs Specialist
il y a 1 semaine
Paris, Île-de-France Planet Pharma Temps pleinJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Planet Pharma. As a key member of our regulatory team, you will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites, while mitigating any risks associated with clinical trial applications and...
-
Regulatory Affairs Specialist
il y a 5 jours
Paris, Île-de-France Apsida Life Science Temps pleinJob DescriptionApsida Life Science is seeking a highly skilled Global Regulatory Affairs Consultant to lead our regulatory strategies for marketing authorization submissions across emerging markets.Key Responsibilities:Lead Global Filing Teams: Coordinate teams to update core documentation and generate country-specific data for submissions.Collaboration &...
-
Regulatory Affairs Specialist
il y a 2 jours
Paris, Île-de-France Meet Temps pleinRegulatory Affairs ManagerMeet our client, a leading organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally.Key ResponsibilitiesManage the regulatory lifecycle of OTC and Consumer products, ensuring full compliance...
-
Regulatory Affairs Specialist
il y a 2 jours
Paris, Île-de-France Meet Temps pleinRegulatory Affairs ManagerMeet our client, a leading organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally.Key ResponsibilitiesManage the regulatory lifecycle of OTC and Consumer products, ensuring full compliance...
Regulatory Affairs Specialist
Il y a 4 mois
Nanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions.
At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the globe.
Nanobiotix specializes in the development and production of nanoparticles that enhance the effectiveness of radiation therapy in cancer treatment. We firmly believe that the synergy between radiotherapy and NBTXR3 has the power to establish a new gold standard in cancer care.
Vos missionsThe CMC regulatory manager is the representative of Nanobiotix by realizing all the regulatory activities linked to the manufacturing of the DS at the site level. As well as by writing and maintaining complete CMC files according to European Medical Device regulations, US drug regulations and any other applicable regulation in countries where products are developed in the frame of clinical trials and marketing authorization applications.
This role includes the regulatory responsibility to support manufacturing audits from Competent Authorities or Notified Bodies. The qualified candidate will serve as the CMC regulatory lead for assigned projects.
Responsible for providing innovative and proactive regulatory assessment to project teams in CMC programs
- Proactively identify regulatory risks for the CMC development product and propose options to mitigate risks
- Lead the planning, strategy content and execution of CMC files for submissions, evaluation processes and approvals.
- Write CMC documents needed for maintenance or registration of regulatory files (Module 3 according to CTD for Drugs and technical/ design documents for Medical Devices)
- Ensure that all CMC documents prepared and to be submitted to regulatory agencies have been evaluated to assure that they are complete, of high quality and in regulatory compliance.
- Participate to manufacturing site audits and ensure that regulatory documents are presented in a way that facilitates agency review
- Participate actively to Change Control Boards to provide accurate regulatory assessment
- Work closely with Quality Assurance department in the coordination/management of CAPA for regulatory CMC topics
- Participate to the Regulatory Intelligence process notably to the general improvement of the process, assessment of updated/amended references impact, applicability of new references to Nanobiotix
- Bring support to the Regulatory Affairs team in the other regulatory activities
- Participate to the Company regulatory compliance
- Extensive knowledge of CMC CTD module 3 writing for drugs is essential.
- Knowledge on technical/design documentation writing for Medical Devices will be highly appreciated.
- Knowledge of laws and regulations affecting the pharmaceutical industry
- Proven track record of successfully leading CMC CTA, IND, NDA/BLA or MAA submissions
- Demonstrated knowledge of drug/Medical device combination
- Ability to analyse and interpret scientific and technical information, as well as regulatory references
- Language: Be fluent in English, mastering the regulatory, technical and scientific English
- Informatics: Be proficient in Offices tools (Excel, Word, PowerPoint and MS Project) and Sharepoint
- Ability to operate successfully (develop strategy, execute on plans, achieve goals, make decisions) in fast-paced, start-up environment
- Excellent communication and leadership skills
- Entrepreneurial, enjoys working in a fast-paced, small-company environment. Ability to function well with volatility, uncertainty, and complexity; to manage pressure, meeting time sensitive deadlines, while maintaining a high level of quality
- Postgraduate qualification (PhD or research-based MSc) in a scientific discipline or equivalent. Advanced degree or Regulatory Affairs Certification is preferred
- 5+ years of pharmaceutical/biotechnology industry experience with CMC management experience
More than premium insurance, prévoyance, CSE advantages, office equipment, meal plans, and mobility allowances, Nanobiotix offers bonuses.
More than premium insurance, prévoyance, CSE advantages, office equipment, meal plans, and mobility allowances, Nanobiotix offers bonuses.
Recruitment process
1. 30 min call with Michael (Talent Acquisition Manager)
2. 45 min interview with Swati (HRBP)
3. 45 min interview with Nicolas (Regulatory Affairs Director)
4. Visit the office to meet the team and Key Stakeholders
Nanobiotix, est une société de biotechnologie. Créée en 2003, elle a développé une méthode qui permet de focaliser les rayons X vers les tumeurs cancéreuses. Elle commercialise un produit dénommé NBTXR3 ou Hensify et le teste dans diverses régions du Monde pour un nombre croissant de cancers.
