FORMA Regulatory Manager (11119) Position Description: As a member of the FORMA Regulatory team, the Regulatory Manager will contribute to the progress of assigned drug candidates. The manager will support program regulatory lead(s) with major filings (INDs, NDAs, MAAs) and work collaboratively with cross functional teams to support development milestones. The RA Manager will also be responsible for managing CROs responsible for Ex-US clinical trial applications including driving submission strategies and timelines, reviewing and approving submission components, and working within FORMA teams to create or obtain required submission documents. The Manager will also take a leadership role in establishing internal regulatory tracking systems and archiving systems and developing regulatory SOPs. The ideal candidate will be a motivated self-starter who thrives in a fast-paced, small team dynamic environment. The RA Manager will be expected to: Compile and manage regulatory submissions for assigned projects Responsible for supporting active INDs and CTAs including planning for and coordinating IND maintenance submissions, managing CROs responsible for clinical trial applications outside of the US and responding to questions Support regulatory lead and contribute to the development and implementation of CMC, nonclinical, and clinical regulatory strategies for projects in all stages of development (pre-IND through commercial) for assigned projects Support preparation for Health Authority interactions including preparing meeting requests and briefing books Responsible for developing or contributing to the development of project timelines and the planning of regulatory milestones Contribute to the continuous improvement of existing department processes and strategies Maintain regulatory archives and submission trackers Contribute to and Develop regulatory SOPs
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