Job Description

• 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 labelling requirements.
• Manages regulatory reporting.

• Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline.
• 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.

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