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Regulatory Affairs Specialist

Durham, NC

Post Date: 06/16/2017 Job ID: 159695 Industry: Other

Assist Regulatory Affairs professionals with administrative tasks associated with global product compliance. Provide data management support with the ability to multi-task and show great attention to detail. Excellent organization, prioritization, and time management skills desired.

Requirements:

  • Hard copy and electronic data organization, entry, and management in multiple systems.
  • Administrative support including compilation of documentation for product information files and regulatory submissions.
  • Communicate with internal and external partners (including vendors and contractors) to gather information and documentation required for global regulatory compliance.
  • Scan, upload, organize, and archive studies, reports, labels, and additional compliance support documentation to maintain regulatory requirements.
  • Update and maintain complete and accurate regulatory compliance records including registrations, certifications, and other recordkeeping requirements.
  • Facilitate requests for information related to products and registrations.
  • Generate reports, maintain regulatory lists, and perform searches.
  • Perform data entry, migration, manipulation, organization, reformatting, and ongoing maintenance in various systems/databases.

Skills:

  • Excellent communication and interpersonal skills.
  • Ability to work in a team environment.
  • Strong computer skills and fluency in applications such as MS Word, Excel, PowerPoint, Adobe Acrobat, Outlook and Internet Explorer.
  • Working knowledge and experience navigating through SAP PDM is a strong plus.
  • Excellent organizational ability, strong attention to detail and documentation skills.
  • Familiarity with cosmetic global registration and compliance requirements a plus.
  • Must be flexible and able to manage a diverse workload and multiple, changing priorities/deadlines.
  • Work collaboratively, effectively and efficiently with all internal/external partners.
  • Scientific or regulatory affairs background/experience a strong plus.

Education:

  • Associates degree or B.S. degree

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