Health Care/Attorney/In House/Morgantown, West Virginia
Location: Morgantown, West Virginia
Description: GCC Consulting is presently looking of Health Care/Attorney/In House/Morgantown, West Virginia right now, this vacancy will be assigned in West Virginia. For complete informations about this vacancy opportunity please give attention to these descriptions. Director, Regulatory Affairs Duties: Direct the preparation of high quality regulatory submiss! ions for assigned projects. Critically review all regulatory submissions, including original ANDAs, amendments, supplemental ANDAs, annual reports, and other related documentation. Generate correspondence to regulatory authorities on specific projects. Maintain awareness of all regulatory activities regarding new and approved drug products. Schedule and distribute regulatory workload. Assign work, answer questions, and provide guidance. Monitor to ensure quality performance and that deadlines are met. Provide performance feedback and coaching to subordinates. Continue the development of positive relationships with the FDA as liaison to CDER on submissions, filings and communications related to the development of drug products. Interact effectively with Product Development, Analytical Development, Quality Assurance, Production, Quality Control, Launch Management, Procurement, and other functional areas. Must provide guidance to other functions and Executive Management with r! espect to regulatory issues. Maintain current knowledge of reg! ulations and other issues that affect products and the industry. Disseminate and discuss with appropriate staff in a timely manner. Review internal documentation such as change control information, method transfer packages, batch record documentation, validation protocols and reports, as required by company procedures. Provide information and submission strategies to minimize regulatory issues and help prevent unnecessary regulatory delays. Maintain regulatory database to ensure fulfillment of regulatory requirements. Participate in CMC issues related to ANDAs/NDAs and INDs, as needed. Interact with other Regulatory Affairs functions to assure coordinated responses. Assist in creating and revising regulatory strategies for new and approved drug products. Work with outside consultants on regulatory issues, as needed. Provide direction to other regulatory professional staff, as needed. Perform other duties as assigned.
Requirements: A B.S./B.A. degree (10-14 y! ears of experience in the Pharmaceutical industry or related field and 8-10 years of experience in Regulatory Affairs); M.S. or PharmD (10-12 years of experience in the Pharmaceutical industry or related field and 6-8 years of experience in Regulatory Affairs); Ph.D, J.D. degree, or MD (6 years of experience in the Pharmaceutical industry or related field and 4-6 years of experience in Regulatory Affairs). However, a combination of education and experience will be considered. Must have expert-level knowledge of FDA regulations and guidance and how the FDA approval process functions. Must demonstrate ability to understand and employ company ?s approaches to working with the FDA. Ability to read and interpret complex business and/or technical documents. Ability to write clear, comprehensive, and concise reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organizati! on.
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If you were eligible to this vacancy, please give ! us your resume, with salary requirements and a resume to GCC Consulting.
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This vacancy will be started on: Thu, 11 Jul 2013 05:21:39 GMT
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