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Regulatory Affairs Operations Specialist

3 months ago


St Joseph, United States Cynet Systems Full time
Job Description:
  • With minimum guidance and supervision prepare regulatory submissions for activities such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, product import, pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting.
  • With minimum guidance and supervision, contribute to the development and implementation of processes and work instructions.
  • Understand and monitor regulatory trends; understand and implement regulations and guidance.
  • Interact with the authorities in a professional manner.
  • Responsive to government agencies for questions on submissions.
  • With minimum guidance and supervision, support systems for product compliance and maintenance.
Skills:
  • Strong requirement for proficiency in MS Office applications and Adobe Acrobat is a requirement.
  • General knowledge in relevant Regulatory Affairs areas.
  • General knowledge and understanding of regulatory legislation and requirements for the maintenance of veterinary products.
  • General knowledge of the legal requirements for maintenance of veterinary medicinal products.
  • Maintains compliance with respect to all requirements for assigned products.
  • Ensures company interests are supported/maintained in negotiations with regulatory authorities resulting from requests and information received from regulatory authorities.
  • Proficient in standard office technology, including Word, Excel, and Adobe Acrobat.
  • I Competencies.
Education:
  • Bachelor's degree and 1 year relevant industry experience OR Associate's degree and 3 years relevant industry experience OR.
  • In lieu of a degree, 5 years relevant industry experience including 1 year of related regulatory experience.