Position Summary:  Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA development and maintenance for support of new and ongoing clinical trials. This role requires an independent, self-directed, and highly motivated clinical regulatory professional. Position Responsibilities: Represent regulatory on study and program teams throughout study conduct and product development. Prepare and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, health authority briefing document, iPSP/PIP, NDA/MAA) Serve as the primary contact with the FDA, and lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required. Provide oversight of regulatory submissions to assure t Apply now and work remotely at Erasca