The successful candidate will Independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration. • Provide expert strategic advice to clients for companion diagnostics and novel devices • Provide global regulatory diagnostics strategic advice to clients including EU and US • Prepare and submit regulatory documents including but not limited to, CE documentation, US Q-submissions, US premarket approvals (PMAs) and notifications • Review of documentation to support gene therapy submissions, including IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance • Lead regulatory agency interaction and negotiations Email Julia Day [email protected], quoting ref 50106