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The Sr. Regulatory Operations Specialist contributes to daily operations activities for preparation of regulatory submissions to FDA, EMA, and other key health authorities. They also collaborate with Regulatory Affairs staff and interdisciplinary teams in the management of submission components and tracking of deliverables. The Sr. Regulatory Operations Specialist is responsible for various aspects and publishing of regulatory submissions as well as the submission components. This includes,....

- Philadelphia, PA

The Regulatory Operations Lead (Reg Ops Lead) will be responsible for driving direction and leadership of regulatory affairs operations. He/she will manage daily cross-functional operational activities for preparation of regulatory submissions. This position is responsible for developing and deploying strategic business solutions, technology, systems and processes that maximize productivity, optimize our resource utilization and ensure adherence to global regulatory and compliance....

- Philadelphia, PA

The Regulatory Affairs Associate, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include amendments, supplements, annual reports, DSURs and additional documents as needed. Compiles and reviews amendments, supplements, annual reports, etc., for FDA and other health authority submissions. Interacts....

- Philadelphia, PA

The Regulatory Affairs Lead will work independently to prepare submissions, which may include INDs/CTAs, Briefing Documents, Orphan Drug Applications, Pediatric Plans and Marketing Applications. Implicit is the ability to work with and represent regulatory function in cross-functional teams to define contributions to submissions and help lead submission teams for projects assigned across Sparks clinical initiatives. He or she will develop, coordinate and implement regulatory, research and....

1-4 of 4 results