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RA Sr Assoc - Regualtory Affairs Assoc Sr - Generic NC Type: Full-Time Category: Regulatory Affairs Job ID: 799 Opportunity Description: (919) Area code          Raleigh/Durham   Regulatory Affairs Specialist   Duties/Responsibilities Coordinate the planning, scheduling, preparation, reviewing, and assembling of regulatory projects and submissions, including developing the content and format of regulatory submissions. Provide support to clinical, quality, and other scientific development disciplines to assure that documentation conforms to applicable regulations and guidelines. Collect, review, organize, assemble and check data reports and summaries, to assure full compliance with the FDA regulations and past agency actions. Maintain working knowledge of regulatory submissions, understanding of product chemistries, manufacturing processes and analytical packages, and their regulatory implication.  Provide advice and suggest strategies as required to facilitate regulatory actions.  Implement and manage approval activities to assure timely market entry.  Provide timely review of technical data, labeling, promotional material, and any other collateral documents that are subject to regulatory control. Coordinate post approval activities (annual reports, adverse event reporting, registrations, field alerts, SUPAC, etc.). Perform regulatory research including regulations, guidance’s, SBAs, FR, PDR, etc. and marketed product labels via the internet or other databases.  Provide timely information to regulatory bodies that may be required for adverse events, field actions, recalls or other such activities.  Maintain required records.  Supervise, as needed any recall activities. Establish and maintain policies and procedures to ensure compliance with government regulations and international Good Manufacturing Practice (GMP). Attend FDA related meetings as necessary. Work closely with R&D Project Manager on a project basis to assure transfer of information in a timely manner. Work with Process Development, Manufacturing, and Quality Assurance to prepare for pre and post approval inspections and final product launch. Education and/or Experience Bachelor’s or Masters degree in a scientific discipline with at least 2 years in pharmaceutical regulatory affairs.   Regulatory Affairs Certification Exam (RAC) certification preferred   If you are interested in the company name and exact location for this opportunity, please enter your email address below.

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