Regulatory Affairs Specialist

2 months ago


Fort Lauderdale, Florida, United States 5TH HQ LLC Full time
Exciting Opportunity: Regulatory Affairs Specialist

A dynamic company, 5TH HQ LLC, is currently seeking a detail-oriented and motivated professional to join their team as a Regulatory Affairs Specialist. This role plays a crucial part in ensuring compliance with regulatory requirements for their products, making it a key position within the organization.

Key Responsibilities:
  • Prepare and review regulatory documents to comply with FDA and other regulatory authorities.
  • Stay updated on regulations, guidelines, and standards in the pharmaceutical industry.
  • Assist in preparing regulatory submissions like NDAs, INDs, and amendments.
  • Collaborate with cross-functional teams to gather information for submissions.
  • Communicate effectively with regulatory authorities.
  • Monitor submission progress and address inquiries from regulatory bodies.
  • Develop and implement regulatory strategies for product approvals.
  • Maintain organized regulatory files and records.
Requirements:
  • Bachelor's degree in biology, chemistry, or pharmaceutical sciences.
  • Prior experience in regulatory affairs within the pharmaceutical industry.
  • Excellent understanding of FDA regulations.
  • Strong organizational and time management skills.
  • Detail-oriented with the ability to manage multiple projects.
  • Effective written and verbal communication skills.
  • Proficiency in Microsoft Office Suite.
  • Ability to work independently and collaboratively.


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