Senior Regulatory Affairs Manager
il y a 3 semaines
Nanobiotix is pleased to present an opportunity for a Senior Regulatory Affairs Manager to become a vital member of our team. In this position, you will significantly contribute to Nanobiotix's objective of pioneering innovative nanomedicine solutions aimed at transforming cancer treatment.
With a focus on the creation and production of nanoparticles that improve the efficacy of radiation therapy for cancer patients, Nanobiotix is dedicated to harnessing the synergistic potential of radiotherapy and NBTXR3 to establish a new benchmark in cancer care.
Your ResponsibilitiesAs the Senior Regulatory Affairs Manager, you will serve as the key representative of Nanobiotix in all regulatory matters pertaining to manufacturing at the site level. You will also oversee the development and maintenance of comprehensive CMC files in alignment with various regulatory standards.
This role encompasses:
- Assessing regulatory risks associated with CMC development products and recommending mitigation strategies
- Directing the planning, strategy, and execution of CMC files for submissions and approvals
- Drafting essential CMC documentation for regulatory files
- Ensuring that all regulatory documents are thorough, of superior quality, and compliant
- Engaging in manufacturing site audits and offering regulatory assistance
- 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
- Capability to evaluate scientific and technical data
- Proficiency in English and office software
- Excellent communication and leadership skills
- Postgraduate degree in a scientific field
- Over 5 years of experience in the pharmaceutical or biotechnology sector
Alongside a variety of benefits such as insurance, office equipment, meal plans, and mobility allowances, Nanobiotix also offers performance bonuses.
The Recruitment Process:
1. Initial 30-minute discussion with the Talent Acquisition Manager
2. 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 committed to making a significant impact on humanity by exploring innovative therapeutic approaches to benefit millions of 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.
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