Direct Hire!!! Regulatory Affairs Manager

A global leader in pharmaceuticals has an excellent opportunity for a Regulatory Affairs Manager! This is a great opportunity to grow with a dynamic company. Excellent benefits offered!The Regulatory Affairs Manager will establish regulatory strategies for submissions and manage document deliverables to assure submission targets are met. Includes review of FDA and/or international submissions as well as internal documents to assure proper implementation of regulatory strategies and adherence to appropriate statutes, regulations, and guidances.Responsibilities: -Formulates regulatory strategy and tactics for all appropriate regulatory submissions (e.g., ANDAs, dossiers, amendments, and supplements) for domestic, international, and/or contract projects. -Coordinates, prepares, and reviews all appropriate regulatory submissions (e.g., ANDAs, dossiers, amendments, and supplements) for domestic, international, and/or contract projects within a specified time frame in conjunction with the organization. -Provides project management support to Labeling Specialist in development and review of draft and final printed product labeling. -Coordinates and reviews development of promotional labeling with Marketing. -Coordinates and reviews for submission bi-annual Drug Listing with Regulatory Labeling Specialist. -Acts as contact representing Regulatory Affairs with FDA, business units, contract customers, and international customers as assigned. -Reviews and analyzes regulatory and related publications to assure compliance and anticipate future regulatory actions both internally and externally. -Follows Safety, Health, and Environmental policies and procedures. -Other duties, as assigned, or as business needs require. Primary Outcomes: -On time submission and approval of applications, amendments, and supplements. -Maintain approved applications in compliance with appropriate statutes, regulations, and guidances. -Provides sound regulatory advice/guidance to business, research, and operations professional staff. -Provides training and coaching to junior RA professional staff members.Experience:-Minimum Bachelor's degree in scientific or healthcare discipline or equivalent combination of education and related experience. -Prefer RAPS RAC (U.S. or EU). -Minimum of five (5) years pharmaceutical industry experience with a least four (4) years in regulatory affairs. -Prefer knowledge of regulatory affairs requirements for sterile drug products. -RAC certification beneficial, but not required; working knowledge of CMC as needed for generic drug submissions. Prior pharmaceutical experience involving chemistry or manufacturing.Kelly Scientific Resources® (KSR) is the world's largest provider of staffing and HR solutions services to the biotechnology and pharmaceutical industry. By consistently providing key personnel in the areas of bioinformatics, combinatorial chemistry, genomics, clinical research and R&D, KSR has earned the reputation of being a quality, innovative staffing provider. KSR is a unit of Kelly Services, Inc., a Fortune 500 company and a global staffing industry leader for over 60 years. Learn more about company