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Compliance Specialist

3 months ago

Fort Lauderdale, Florida, United States 5TH HQ LLC Full time
Join Our Team: Compliance Specialist

5TH HQ LLC is on the lookout for a meticulous and driven individual to fill the role of Compliance Specialist. This position is vital in ensuring that our products adhere to regulatory standards, making it an essential function within our organization.

Key Responsibilities:
  • Draft and evaluate compliance documentation to meet the requirements set forth by regulatory agencies.
  • Keep abreast of the latest regulations, guidelines, and standards pertinent to the pharmaceutical sector.
  • Support the preparation of compliance submissions, including new drug applications and investigational new drug submissions.
  • Work collaboratively with various departments to collect necessary information for submissions.
  • Engage in effective communication with regulatory bodies.
  • Track the progress of submissions and respond to inquiries from regulatory authorities.
  • Formulate and execute compliance strategies for product approvals.
  • Ensure that regulatory files and records are meticulously maintained.
Qualifications:
  • Bachelor's degree in biological sciences, chemistry, or pharmaceutical studies.
  • Previous experience in compliance within the pharmaceutical field.
  • Thorough knowledge of regulatory standards.
  • Exceptional organizational and time management abilities.
  • Detail-oriented with the capacity to handle multiple projects simultaneously.
  • Strong written and verbal communication skills.
  • Proficiency in Microsoft Office applications.
  • Able to work both independently and as part of a team.