Regulatory Affairs Manager

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Job description

Responsibilities:

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.

Requirements:

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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