Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).
Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates.
The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin.
The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.
The Regulatory Affairs Manager reports to the Regulatory Affairs & Quality Assurance Director.
The Regulatory Affairs Manager Develop and lead the regulatory strategy for assigned products in development according to regulations and global project timelines.
The Regulatory Affairs Manager is a permanent position based in Montpellier or Paris.
- Lead the planning, strategy content and execution of filings and approval during development until registration
- Proactively identify regulatory risks to the strategic and operational/tactical plans and propose options to mitigate risks
- Lead and supervise the planning and preparation (including authoring where appropriate) of routine and complex documents, including CTA/INDs , orphan drug designation, briefing documents for scientific advice and agencies meetings as appropriate
Regulatory internal and external contact point
- Responsible for providing innovative and proactive strategic leadership to project teams in preclinical stage programs
- Guide project teams to implement appropriate regulatory strategies
- Provide regulatory due diligence as needed
- Work closely with Alliance partners as applicable
- Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review
- Provide Sensorion with current and proposed regulatory, scientific and pertinent legal issues
- Speak on behalf of the company at conferences or professional association on regulatory affairs topics
- Define and maintain regulatory budget for the assigned products
- Mentor the regulatory affairs specialists as applicable
- Minimum B.A./B.S. or higher degree(s) in the sciences, or health related field
- Advanced scientific degree preferred PhD/Pharm D/MD
- 5+ years of pharmaceutical/biotechnology industry experience with technical management experience
- Experience in biologics and gene therapy are essential
- Knowledge of laws and regulations affecting the pharmaceutical industry
- Must have prior experience working with EMA and FDA
- Minimum of 2 years of experience in as a Regulatory Manager;
- Knowledge of medicinal product life cycle from clinical trial to NDA/BLA or MAA of successful NDA and/or BLA filing essential;
- Ability to analyse and interpret scientific and technical information, as well as regulatory documents;
- Fluent in English, both written and verbal.