Executive Director, Head of Regulatory Affairs
Allena Pharmaceuticals Inc.
Janaki (Jana) M. Subramanyam, MS, RAC, Executive Director, Head of Regulatory Affairs, Allena Pharmaceuticals, Inc.
Regulatory Affairs professional with 20 years strategic experience with FDA, EMA and Health Canada regulations. Proven history of successful leadership of teams including multiple approvals (drugs, biologics & medical imaging agents). Strategic and operational oversight of regulatory activities; including Clinical, Preclinical & Manufacturing development, global Phase II & Phase III clinical trials, approval of products in the United States, Europe and Canada. Skilled liaison with proven leadership skills and experience interfacing with external organizations, regulatory agencies for US, Canada & EMA in support of Company submissions and Health Authority inspections (Pre-Approval and Pharmacovigilance). Strengths include providing strategic input to cross functional teams, management of departmental operations, project management related to submission activities, as well as leading and mentoring multi-functional teams. Exceptionally organized and articulate; possessing strong interpersonal skills and a flexible work style to effectively collaborate with individuals at all levels in a matrix environment.
Wednesday, September 16, 2020
10:35 AM – 11:30 AM EDT