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Vice-président des affaires réglementaires / Vice-President of Regulatory Affairs (RA VP)
Valide du: 01/18/2019 au 02/18/2019
The Vice-President of Regulatory Affairs (RA VP) is a key member of the leadership team and provides both strategic and hands-on leadership with the introduction and approval of innovative cell therapy products. The position will have overall accountability for leading the preparation of regulatory submissions to support clinical development of cell therapy product candidates. As such, this role calls for a hands-on leader who will be responsible for writing and preparing FDA CBER IND submissions and interacting with the regulators. This role requires a broad scope of cell therapy experience. This role also requires the ability to influence a diverse group of stakeholders (both internally and externally).
Key responsibilities include, but are not limited to:
- Prepares briefing and regulatory documents for regulatory agencies, such as Dossiers, INDs, NDAs, and Annual reports.
- Maintains awareness of global regulatory environment for cell therapies and regenerative medicine including accelerated review programs and provides guidance and information to the Senior Management Team to ensure use of the desired regulatory strategies.
- Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in many major global markets.
- Defines country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication and negotiation with global regulatory agencies with intelligence and diplomacy, and leading the company’s effort in definitive submissions.
- Oversees quality checks, compilation, electronic processing and publishing of submissions to ensure high quality electronic submissions compliant with regulatory authority requirements.
- PhD in cell biology and at least ten (10) years of progressive experience in regulatory affairs within the biopharmaceutical industry, or equivalent.
- Experience in development, manufacturing and testing of cell therapeutics is highly desirable.
- Experience with Health Canada CTA process is considered a strong plus.
- Extensive experience in preparing regulatory filings including IND/CTA, pre-NDA/BLA/MAA, and other major regulatory submissions.
- Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
- Knowledge and understanding of international regulations and ICH guidelines related to cell therapy development.
We are firm believers that the diversity of our ideas, perspectives and people promote innovation and is one of our key strengths. Fortuna Fix cultivates employment equity and encourages applications from all groups.
If you are passionate about bringing real solutions to critical health conditions, we want to hear from you. Send us your resume at email@example.com and a real human will review it. A cover letter justifying your interest gets our relationship off to a great start!
Description ; Fortuna Fix is a regenerative medicine company focused on neuronal repair and regeneration. We have developed a leading-edge technology in the field of neural cell therapeutics with a vision of developing personalized products to transform the CNS field. Our patented technology portfolio includes autologous neural precursor cells produced by direct reprogramming (drNPC™) and regenerative implants (RMx™) along with fully Automated Manufacturing for rapid scale-up and production of the drNPC™.