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il y a 3 semaines
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Senior Regulatory Affairs Manager
Il y a 2 mois
Nanobiotix is thrilled to present an opportunity for a Senior Regulatory Affairs Manager to join our dedicated team. In this pivotal role, you will contribute significantly to Nanobiotix's vision of pioneering innovative nanomedicine solutions aimed at transforming cancer treatment.
As a leader in the development and production of nanoparticles that improve the efficacy of radiation therapy for cancer, Nanobiotix is committed to harnessing the synergistic potential of radiotherapy and NBTXR3 to establish a new benchmark in cancer care.
Your Key ResponsibilitiesIn the capacity of Senior Regulatory Affairs Manager, you will serve as the primary liaison for all regulatory matters concerning manufacturing at the site level. Your responsibilities will include drafting and maintaining comprehensive CMC documentation in adherence to various regulatory standards.
This position entails:
- Assessing regulatory challenges for CMC development products and suggesting viable solutions
- Overseeing the planning, strategy, and execution of CMC documentation for submissions and approvals
- Composing essential CMC documents for regulatory submissions
- Ensuring the completeness, quality, and compliance of all regulatory documentation
- Engaging in manufacturing site audits and offering regulatory guidance
- In-depth knowledge of CMC CTD module 3 documentation for pharmaceuticals
- Familiarity with technical/design documentation for medical devices
- Comprehensive understanding of pharmaceutical laws and regulations
- Proven experience in leading CMC submissions
- Ability to interpret scientific and technical data
- Proficiency in English and Microsoft Office tools
- Excellent communication and leadership skills
- Postgraduate degree in a scientific field
- Minimum of 5 years of experience in the pharmaceutical or biotechnology sector
Alongside a range of benefits such as health insurance, office equipment, meal plans, and mobility allowances, Nanobiotix also provides performance-based bonuses.
The Recruitment Process:
1. Initial 30-minute discussion with the Talent Acquisition Manager
2. Follow-up 45-minute interview with HR Business Partner
3. 45-minute interview with the Regulatory Affairs Director
4. On-site meeting with the team and key stakeholders
Founded in 2003, Nanobiotix, headquartered in Paris, France, is a biotechnology firm at a clinical and advanced stage. The company is dedicated to making a significant impact on humanity by exploring innovative therapeutic approaches to benefit countless patients globally.
Nanobiotix has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York since December 2020. With subsidiaries, including one in Cambridge, Massachusetts (USA), the company is at the forefront of developing transformative therapies.
