Senior/Executive Director Regulatory Affairs

Title: Senior/Executive Director Regulatory Affairs
Summary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.
The S/E Director of Regulatory Affairs will be responsible for: Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teamsLead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risksMonitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategyPrepare and lead teams in regulatory meetings and interactions with notified bodiesLead the authoring and review of regulatory documents in a timely mannerLead department initiatives and assist in training and oversight of the RA teamQualifications: 10+ years in Regulatory Affairs in biopharma industry or equivalentExtensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products and IVDs (IDE/IND/CTA/BLA/NDA)Ability to develop and implement regulatory strategies in the Oncology fieldExperience working with regulatory agencies and effectively move products through the development processHighly collaborative working style with the ability to work in cross-functional

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