Keywords: [REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD] Title: Senior Manager of Regulatory Affairrs Role: Reporting to the Senior Director of Regulatory Affairs, you would be responsible for taking a lead role in driving regulatory strategy. This is an extremely exciting opportunity inNew Yorkoffering a competitive salary as well as generous benefits. The position demands an extremely strong analytical and technical understanding, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas. Responsibilities: - Provide strategic regulatory support to all functional groups in alliance projects with contract manufacturers. -Represent RA on various product teams - Create, organize and manage the preparation of all types of FDA submissions -Coordinate, compile and submit regulatory applications -Organize and maintain reporting schedules for regulatory applications -Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals. - Respond to queries from FDA associated with NDA submissions -Take lead roles in pre-IND meetings and FDA conference calls - Independently review and provide feedback to the promotional review committee related to promotional marketing items. Requirements: -Minimum of an MS degree in life sciences or related field, ideally a PhD or advanced degree - At least 4 years of experience in the pharmaceutical industry including 5 plus years regulatory affairs -Experience reviewing outgoing FDA correspondences -Experience with INDs, NDAs, BLAs, and other regulatory submissions -Prior experience interacting with the FDA - Knowledge of eCTD publishing software preferred -A strong strategic background Initial phone screenings will be conducted by the end of this week and slots are filling up fast!!
To find out more about Real please visit
www.realstaffing.com [1]
Links:
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[1]
http://www.realstaffing.com