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:
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Providing regulatory leadership and guidance to project teams and work collaboratively with cross functional teams
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Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks
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Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy
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Prepare and lead teams in regulatory meetings and interactions with notified bodies
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Lead the authoring and review of regulatory documents in a timely manner
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Lead department initiatives and assist in training and oversight of the RA team
Qualifications:
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10+ years in Regulatory in biopharma industry or equivalent
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Must have experience in Oncology biologics
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Extensive experience of regulatory requirements and early to late-stage experience with US, EU, and RoW submissions for therapeutic products (IDE/IND/CTA/BLA/NDA)
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Ability to develop and implement regulatory strategies in the Oncology field
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Experience working with regulatory agencies and effectively move products through the development process
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Highly collaborative working style with the ability to work in cross-functional teams