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Regulatory Assistant

3 months ago

Columbia, United States LHH Full time

LHH is seeking a Regulatory Assistant on a contract basis, starting immediately

The Regulatory Assistant will support the Regulatory Affairs department in ensuring that the company complies with all relevant regulations and standards. This role involves preparing and submitting regulatory documents, maintaining records, and coordinating with various internal departments and external agencies. The ideal candidate is detail-oriented, highly organized, and possesses excellent communication skills.

Key Responsibilities:

  • Assist in the preparation, review, and submission of regulatory documents to ensure compliance with local, regional, and international regulations.
  • Maintain up-to-date knowledge of regulatory requirements and guidelines.
  • Support the development and implementation of regulatory strategies.
  • Coordinate with internal departments to gather necessary documentation and information for regulatory submissions.
  • Maintain and organize regulatory files, records, and databases.
  • Monitor and track regulatory submission status and follow up as needed.
  • Assist in the preparation for regulatory inspections and audits.
  • Conduct research on regulatory issues and provide summaries and recommendations.
  • Communicate with regulatory agencies and respond to inquiries under the supervision of the Regulatory Affairs Manager.
  • Assist in the preparation and review of product labeling, packaging, and promotional materials for regulatory compliance.
  • Perform administrative tasks such as scheduling meetings, preparing agendas, and taking minutes.

Qualifications:

  • Bachelors degree in a relevant field such as life sciences, pharmacy, or a related discipline.
  • Previous experience in regulatory affairs or a related field is preferred.
  • Strong understanding of regulatory requirements and guidelines.
  • Excellent organizational skills and attention to detail.
  • Strong written and verbal communication skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Ability to work independently and as part of a team.
  • Strong problem-solving skills and ability to manage multiple tasks simultaneously.