Sr. Mngr, Drug Regulatory Affairs

Welcome to Novartis - the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.The Sr Mngr may function as a DRA representative responsible for assuring the regulatory integrity of assigned investigational and marketed products. This associate is the primary liasion between Novartis and the FDA, interacting with FDA officials up to the level of supervisory reviewers. This person will be the sole DRA representative on assigned international project teams, and will obtain input from regulatory staff in key affiliated companies. They are responsible for designing and implementing registration strategies for assigned compounds that will lead to optimal worldwide registration and will review and assess the accuracy and appropriateness of all submissions to the FDA and/or major documents to foreign health authorietes. They will coordinate all meetings with the FDA and will assist in clearance of promotional materialsQualificationsStrong knowledge of US regulatory affairs and FDA regulations and good understanding of the drug development process is required. Candidates must possess a Ph.D. in a biomedical science, Pharm.D., or equivalent and must have 8-10+ years experience in regulatory affairs. Knowledge of EU or Asian regulatory affairs is desirable and will place the candidate at a signficant advantage. Strong interpersonal oral and written communication skills are mandatory for effective interactions with Novartis worldwide and regulatory authorities. Knowledge of Novartis international drug development process and computer skills are highly desireable. This position would be ideal for a candidate who meets the above requirements and has also had significant exposure to Oncology projects. Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.