Global Program Regulatory Manager job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Participates in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC).|
Ensures that pre-clinical and clinical trials designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission. May coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices. Applies extensive technical expertise and has full knowledge of other related disciplines. Develops technical solutions to complex problems which require the regular use of ingenuity and creativity. Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results. Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Represents organization as prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizationsPharmD or PhD with 2-4years' experience. English. Oncology background highly preferred. Successful candidate should have a strong knowledge of regulatory submission and approval processes in regions. 4-6 years regulatory and drug development experience in Ph I-IV.