BLA experience is essential
Strategic with health authorities, the company has a product going through BLA filing/ commercialization this year and they need someone who understands this process and has direct experience with FDA and other authorities
A minimum of 10 years of pharmaceutical and drug development regulatory experience, as well as a background in dealing with the FDA and preferably European regulatory authorities in US-based Pharma/Biotech, is required for this position.
Experience working in a small biotech environment
Experience in both oncology/non-oncology drug development is preferred, though not required.
Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC, and Clinical, with a track record of successful submissions and license approvals with CDER or CBER
Extensive knowledge of clinical development, FDA and international global clinical trial regulations and relevant requirements
A demonstrated ability to manage regulatory activities and deliver against program timelines
Exceptional qualitative and analytical/quantitative skills
Demonstrates outstanding leadership capabilities, ability to
Works with diverse stakeholders and builds strong, collaborative relationships
Exceptional verbal and written communication skills
Excellent organizational, interpersonal, communication, and negotiation skills
RAC certification is helpful but not necessary
Radiopharmaceutical experience is a bonus/preferred but not essential

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VP of Regulatory Affairs