Regulatory Affairs Specialist


BluChip Solutions

2020-05-21 21:57:34

Job location Wexford, Pennsylvania, United States

Job type: fulltime

Job industry: I.T. & Communications

Job description

MUST HAVE PHARMACEUTICAL EXPERIENCE ROLE AND RESPONSIBILITIES Prepare, review and maintain compliance and regulatory documents to ensure accuracy, quality, and integrity Review all regulatory agency submission materials to ensure timeliness, accuracy, and comprehensiveness, work with submissions management vendor to maintain submissions Maintain files and retrieve requested documents during inspections, audits, traceability exercises, recalls, business continuity, etc Provide responses to regulatory agencies regarding product information, audits, or issues bull Evaluate applicable laws and regulations to determine impact on company activities and processes Perform other duties as assigned QUALIFICATIONS AND EDUCATION REQUIREMENTS 3+ yearsrsquo experience in technical writing Experience in pharmaceutical regulatory roles Experience with the following regulations FDA, GMPs, CFRs bull Strong attention to detail Advanced written and verbal communication skills Time management and prioritization skills Ability to work well with various departments in the company PREFERRED SKILLS Good verbal and written communication skills Computer skills (Microsoft Windows and Office programs), Certification in a regulatory discipline preferred

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