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Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Tampa, FL, US • published 2026-09-29 02:55:16.068217

Description

**Responsibilities:*** Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. * Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. * Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. * Evaluate the risk of proposed regulatory strategies; may offer solutions. * Reviews proposed labeling for compliance with applicable US and international regulations. * Writes/manages the development of package inserts. * Reviews and evaluates promotion and advertising material for compliance with applicable regulations. * Reviews proposed product changes for impact on regulatory status of the product. * Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. * Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. * Provides regulatory direction to development project teams as a core team member...

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