SENIOR VICE PRESIDENT OR VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS
Nanobiotix – a brief history
Est. 2003, Nanobiotix is a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment. Headquartered in Paris (c.70 staff) and with a US affiliate in Cambridge, MA (c.20 staff), Nanobiotix designs and manufactures nanoparticles that safely enhance the efficacy of radiation therapy.
Nanobiotix first received authorization to start the pilot phase I/II clinical study in humans in 2011. Filing of the CE Marking Application for NBTXR3 in Soft Tissue Sarcoma came in 2017, followed by positive phase II/III results for NBTXR3 in Soft Tissue Sarcoma. European market approval for NBTXR3 in this indication was achieved in 2019. Nanobiotix were publicly listed on the Nasdaq stock exchange in 2020 – a total raise of S$113.3 million.
JOB DESCRIPTION
Key responsibilities:
- Develop the overall US and ROW regulatory strategy for development programs
- Lead and manage health authority relationships, communications, and negotiations
- Maintain current CE Mark in EU
- Provide strategic regulatory leadership, guidance, and training for all clinical development projects to staff, both direct and in-direct, and interface with key stakeholders
- Lead regulatory risk assessment and mitigation
- Lead the regulatory function on cross-functional development teams and ensure that all are appropriately informed of US, EU, and other regulatory requirements
- Ensure that all components of manufacturing and quality programs relevant to the CMC components are aligned to meet US, EU, and other regulatory requirements
- Manage and communicate regulatory expectations to vendors (CROs, CMOs, consultants, etc.) to ensure compliance and regulatory strategy alignment
- Plan, participate in, and review submissions to regulatory authorities including FDA, EU and other health authorities (IND, CTA, NDA, MAA, etc.) throughout the lifecycle of company portfolio and ensure accuracy, and provide sign-off on all documents presented to regulatory agencies
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities, in addition to responding to requests for information
- Provide interpretation of and advice regarding regulations, directives, and guidance
- Hire, train, and manage regulatory affairs department (currently six staff)
CANDIDATE SPECIFICATION
Essential:
- Extensive senior-level experience in regulatory affairs
- 18+ years of industry experience; 15+ years specifically focused in regulatory affairs
- People management experience
- Experience with having led the regulatory aspects of an oncology product, through development to successful registration, either in the US or Europe
- Knowledge of US FDA drug regulations
- Experience with FDA, MDR, and ICH guidelines both strategically and operationally including formal interactions with regulatory agencies
- Experience leading regulatory aspects of late-stage drug development through to market
- Demonstrated experience and expertise in preparing complex regulatory documents including INDs, NDAs, and other major regulatory submissions
- Regulatory Affairs certification (RAC) in US and EU (strongly preferred)
Preferred:
- Experience of interacting directly with the FDA, i.e., leading discussions and articulating complex concepts
- Large pharma and biotechnology company experience
- Experience with first in class drugs
- Experience with injectables
- Understanding of EU device regulations
- Advanced degree
Important Attributes:
- Proven leadership skills in a growing global company environment
- Entrepreneurial, with a willingness to challenge the status quo
- Strong interpersonal skills to quickly gain confidence both with internal stakeholders and externally among regulatory agencies
- Able to contribute beyond their functional expertise to build a successful oncology company
- Ability to manage relationships at the highest levels with health authorities, navigating complex regulatory components
- Creative and agile with a hands-on approach
- Able to work with some level of ambiguity, i.e., an environment where SOPs are being created on an ongoing basis
- Driven by a need to help all patients who may benefit from Nanobiotix’s technology and approach
- Interested in the greater good of assisting patients in need
TERMS & CONDITIONS OF EMPLOYMENT
The salary and terms of employment will be discussed in detail at an appropriate stage of an interview with Nanobiotix. The following should serve as a guide only:
-Competitive base salary
-Performance related bonus
-Relocation assistance, where required
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