Head of Global Regulatory Affairs
Creation – Permanent contract
Reporting to the Chief Medical Officer (CMO), you will head all Regulatory Affairs activities worldwide for Poxel and its portfolio. You will be responsible to ensure timely registration with worldwide Regulatory agencies and in particular in US, EU and Japan as well as to develop competitive regulatory strategies for each asset of Poxel.
Your main responsibilities are:
- Leading Imeglimin Phase III worldwide regulatory program
Lead all Japanese Regulatory activities related to the Phase III registration program for Imeglimin in close collaboration with Dainippon Sumitomo Pharmaceuticals (DSP), partner of Poxel for the development and registration of Imeglimin in Japan. This will include a strong collaborative effort with the DSP colleagues as well as a strong understanding of the Japanese Regulatory environment.
Ensure that Poxel’s interests are appropriately represented in the Imeglimin filing phase in Japan and broadly in Asia, including China, and that it is as well aligned with the overall regulatory strategy for the rest of the world, mainly EU/US.
Ensure and play a proactive role in advising and understanding the Regulatory activities that Roivant Sciences, the US/EU/ROW partner for Imeglimin, is developing and implementing.
- Leading PXL770 and PXL065 worldwide regulatory program
Lead the development of a strong Regulatory strategy for PXL770 and PXL065 in the NASH indication.
Understand the NASH current regulatory environment in EU/US/Asia/ROW.
Lead future interactions with EMA and FDA for End of Phase 2 meeting and Registration program to support the NASH indication.
- Leading regulatory strategies for new assets
Play a key role in evaluating regulatory options for new business development assets and drive the strategic decision from the Regulatory perspective.
Understand standard and alternative approaches to registration for small molecules in the area of Metabolic Disease.
- Leading Regulatory Affairs Operations
Lead the development of regulatory operations including the prioritization of internal or external resources to best support the several clinical programs from early phases to filing and registration.
Ensure high quality for Regulatory documentations and dossier.
Anticipate Regulatory Project management for each of Poxel’s assets with regards to timelines and execution.
Your profile :
You have a MD or PhD or similar advanced degree in relevant scientific field (e.g. pharmacology, molecular biology).
You have a minimum of 10-15 years’ professional experience in the biotechnology/pharmaceutical environment in the development of biological and pharmaceutical products.
You have a minimum of 7 years’ senior-level experience interacting with competent authorities, in particular, the FDA, EMA and PMDA.
You have strong knowledge of the Regulatory environment in US, EU and also Japan.
Extensive leadership, management and project management experience in the multiple facets of drug regulatory affairs and drug development.
You have strong strategic skills and an outstanding written/verbal communication. You have proven ability to manage complex projects, with the flexibility and adaptability to re-prioritize workload to meet changing timelines.
You are an independent leader with strong passion for Clinical Research, Clinical Development and/or Medical Affairs.
You have an entrepreneurial spirit, you are agile and flexible in a rapidly changing environment.
You have strong ability to both think strategically and, in the meantime, be hands-on, pay attention to details and be involved in the everyday aspects for all regulatory activities. You are thrive in a multicultural environment and have strong collaborative skills. You are teamwork orientated.
Position based in Burlington, Massachusetts, USA.
Applications will be pre-screened and not all applicants may be included in the selection process. Candidates interested to apply may contact the HR team (email@example.com).
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