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Program Manager - Scientific - Senior
Ref No.: 18-13377
Location: Cambridge, Massachusetts
Start Date / End Date: 10/09/2018 to 07/08/2019
• For assigned projects, is responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to provide project management support to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.
• Manages and provides supports with the planning and execution of high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. This includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.