Vice President Regulatory Affairs

2 months ago


Long Island City, United States Meet Recruitment Full time

VP or SVP Regulatory Affairsopportunity with an Oncology focused biotech in the Boston areaDevelop and implement robust regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards.Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on all product candidates.Work cross-functionally with various teams (CMC, Clinical, external consultants, etc.)Advanced degree in life science related field with 12+ years in the biotechnology industry.Proven experience leading major Regulatory submissions including CTA, BLA, etc.Advanced working knowledge of the US Regulatory landscape including regulatory, compliance, and quality guidelines for oncology programs.



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