Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.
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.