Provide senior-level regulatory CMC expertise for small-molecule products, focusing on Chemistry, Manufacturing, and Controls (CMC) compliance.
Interpret North American regulatory guidelines and support product lifecycle activities, including reporting and surveillance.
Collaborate with cross-functional teams in an international environment, applying drug development knowledge to complex regulatory needs.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses technology to ensure fair and efficient application reviews, while the partner company this role is listed for is a global life sciences consulting firm with international experts and a collaborative culture.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.