Regulatory Affairs Specialist
il y a 4 semaines
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 Swaty (HRBP)
3. 45 min interview with Nicolas (Regulatory Affairs Director)
4. Visit the office to meet the team and Key Stakeholders
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