Regulatory Affairs Expert

7 days ago

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

We are currently seeking a detail-oriented and motivated Compliance Specialist to join our dynamic team at 5TH HQ LLC. This role is crucial in ensuring that our products comply with all regulatory requirements, paving the way for successful product approvals and lifecycle management.

Key Responsibilities:

  • Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities, guaranteeing seamless interactions with cross-functional teams.
  • Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry, leveraging this expertise to drive regulatory strategies and submissions.
  • Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments, utilizing strong organizational and time management skills to meet deadlines.
  • Coordinate with cross-functional teams to gather necessary information for regulatory submissions, fostering effective communication and collaboration.
  • Ensure timely and accurate communication with regulatory authorities, providing exceptional support throughout the submission process.
  • Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies, maintaining a proactive and organized approach.
  • Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management, driving business growth and success.
  • Maintain accurate and organized regulatory files and records, adhering to industry standards and best practices.

Requirements:

  • Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences, providing a solid foundation for regulatory affairs expertise.
  • Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred, with a proven track record of successfully navigating complex regulatory landscapes.
  • Strong understanding of FDA regulations and guidelines, enabling informed decision-making and strategic planning.
  • Excellent organizational and time management skills, allowing for efficient prioritization and task completion.
  • Strong attention to detail and ability to handle multiple projects simultaneously, ensuring high-quality outcomes and meeting deadlines.
  • Effective communication skills, both written and verbal, facilitating seamless collaboration and stakeholder engagement.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), supporting data-driven decision-making and presentation development.
  • Ability to work independently and as part of a team, adapting to changing priorities and environments.

Compensation: The estimated annual salary for this position is $80,000 - $110,000, depending on qualifications and experience, plus additional benefits and incentives.

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