Regulatory Affairs Specialist

1 week ago


Fort Lauderdale, Florida, United States 5TH HQ LLC Full time

We are seeking a detail-oriented Compliance and Regulatory Expert to ensure our products comply with all regulatory requirements.

Job Description

In this role, you will be responsible for preparing, reviewing, and submitting regulatory documents to ensure compliance with FDA and other regulatory authorities. You will maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.

  • Prepare and submit regulatory documents, including NDAs, INDs, and amendments.
  • Maintain accurate and organized regulatory files and records.
  • Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
  • Ensure timely and accurate communication with regulatory authorities.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a related field, such as biology, chemistry, or pharmaceutical sciences.
  • Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
  • Strong understanding of FDA regulations and guidelines.
  • Excellent organizational and time management skills.
  • Strong attention to detail and ability to handle multiple projects simultaneously.

Estimated salary: $85,000 - $110,000 per year.



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