Global Regulatory Affairs Strategist

Are you an experienced Regulatory Affairs Strategist? Are you interested in being the Regulatory Representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead? If so, our Biotechnology client is looking for individuals just like you!
The successful candidate will be a member of a diligence team, responsible for contributing to the diligence on behalf of regulatory affairs and will be empowered to seek optimal strategies and challenge assumptions to meet in-scope objectives and milestones. You will also be responsible for the assessment of information that will lead to a regulatory recommendation.
You will also identify and assess regulatory risks associated with product development and define strategies to mitigate risks in alignment with the global business strategy. You may represent the company to the FDA or EMA as well as to corporate partners.
This is a contract position, inside IR35, offered initially on a 6-12 month contract basis working 37.5 hours a week time Mon-Fri.
Responsibilities:
Being part of an internal diligence team, with personal responsibility to provide strategic and technical regulatory guidance to the diligence team for external diligences. This includes working with external companies and the internal diligence team on discrete products for multiple indications, from pre-clinical development through life cycle management.