Remote Regulatory affairs Jobs

• Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
• Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
• Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.

• Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
• Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
• Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.

Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.