Remote Regulatory affairs Jobs โ€ข FDA

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Senior Regulatory Manager, Quality

Fullscript โš•๏ธ๐Ÿ’Š๐Ÿ“ˆ

The Senior Regulatory Manager plays a key role in leading regulatory strategy and ensuring compliance across our diverse product ecosystem, from supplements and cosmetics to diagnostic test kits and food products. Youโ€™ll lead and empower a growing Regulatory team, work collaboratively with Quality, Legal, Distribution, and Brand teams, and provide strategic oversight for regulatory readiness, audits, labeling compliance, and supplier qualification.

Senior Director, Regulatory Affairs

Dianthus Therapeutics ๐Ÿงช๐Ÿงฌ๐Ÿ”ฌ

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for the multifocal motor neuropathy (MMN) program and supporting other programs as needed. You will provide expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.