Mid-Senior RA specialist
On Assignment, Inc./Oxford Global Resources

Salem, Oregon

Posted in IT
9 days ago


Job Info


Summary:

Actively contribute to the development and implementation of regulatory strategy for assigned projects.

Project Details:

  • Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, NDAs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Provide thoughtful & accurate comments during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content
  • Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
  • Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings
  • Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.)
  • Monitor company progress toward fulfillment of regulatory commitments
  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
  • Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines)
  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts
  • Develop and maintain current regulatory knowledge
  • Handle multiple projects and exercise good judgment in prioritizing tasks

Job Experience:
  • 5 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility
  • Experience working with innovator products and designing and executing creative development strategies are highly desirable
  • Must have a solid understanding of FDA regulations and ICH guidance's, as well as a comprehensive knowledge of the drug development process
  • Experience with regulatory submissions, including INDs, NDAs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential

Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefits@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.



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