Job Description
Lead the authoring and preparation of meeting packages for regulatory CMC interactions in the US and globally. Develop and review content for Mod 2 and 3 for all regulatory filings and information requests. Support the development of CMC regulatory strategies for Orca Bio products (early- to late-stage/registration/post-market). Work with cross-functional teams to ensure regulatory packages align with overall development objectives and timelines. Identify and communicate regulatory risks, supporting the development of strategies to mitigate risks.
About Orca Bio
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies.