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Manager, Regulatory Affairs

Company: Ascent
Location: Irvine
Posted on: November 10, 2019

Job Description:

19-09598/Manager, Regulatory AffairsLocation: Irvine, CAIndustry: Biotechnology / PharmaPosition Type:? Contract??Summary of Job:This position will execute CMC projects within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics and device/biologics combination products.?Job Duties:? Execute and manage the implementation of Regulatory CMC strategy.?? Management of regulatory assessments and notifications with change control system.?? Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes.?? Actively participate in project team meetings and provide leadership in meeting submission goals.?? Determines nature, scope and format of CMC information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain and maintain market approval for development and approved products.?? Manages response team for regulatory agency CMC inquiries.?? Administers preparation of briefing and presentation materials for Regulatory Agency meetings.?? Represents Regulatory Affairs CMC on project teams for assigned products/projects.??Qualification/Education:?B.S. required in related scientific discipline with a minimum of 2+ years of regulatory CMC experience and 4+ years of pharmaceutical, biologics or related, experience.? Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment.?? Business and personal computer hardware and software applications.?? Excellent written and verbal communication, presentation, and facilitation skills?? Collaborate with management to develop appropriate regulatory strategy.?? Interpret global regulations and apply Health Authority guidance to the development of CMC regulatory documentation.?? Establish strong working relationships within the project teams by proactively managing global CMC strategies, submissions, and timelines.?? Work independently to prioritize and manage multiple projects and assignments.?? Ability to build bridges between diverse groups of stakeholders.?Preferred Skills/Experience:? Pharmaceutical manufacturing facility/development laboratory preferred.?? Experience in the preparation and management of regulatory submissions including experience in preparation of responses to issues raised by global Health Authorities.?? Global registration support.?? Perform regulatory assessments in a cGMP change control environment.?? Sound basis of Scientific (Training/Communications) knowledge in multiple areas?? Demonstrated ability to prepare and manage ensure thoroughness, and accuracy of global CMC dossiers.?? Ability to handle multiple assignments and prioritize work independently.?? Experience with biologics products??**For immediate consideration please e-mail mvespoli@ascentsg.comAbout Ascent:The Ascent Services Group (ASG) is a nationally recognized staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences.? As consultants for ASG, you will have access to many of the top clients within the industries we serve.? Our goal is to deliver innovative talent through proven best practices and effective resource optimization.? Become one of ASG's candidates and experience the difference!??

Company Description:

About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Irvine , Manager, Regulatory Affairs, Executive , Irvine, California

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