March 29
🏢 In-office - Bay Area
• Manages most aspects of company regulatory interface with domestic and international health authorities. • Manages the development and deployment of the regulatory program that ensures aggressive product approval. • Manages and may generate regulatory submission documents for new products or changes to existing health authorities' filings, including domestic and international submissions and registration. • Manages the submissions of clinical study submissions. • Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance. • Partners with various teams throughout organization (Clinical Operations, R&D, Quality, etc.) on projects. • Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations. • Provides guidance with localization and labeling requirements. • Manages regulatory reporting
• 5 + years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries • Strong analytical and problem-solving skills. • Strong written and verbal communication skills, including the ability to interact effectively and to influence. • Strong attention to detail. • Customer focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations. • High functioning as both a team player and individual contributor • Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline
• Pay range $180,000 - $210,000 • Onsite in Menlo Park, CA 3 days per week
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