Remote Senior Manager of Regulatory Affairs

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Azurity Pharmaceuticals

πŸ“Remote - United States

Job highlights

Summary

Join Azurity Pharmaceuticals as a Regulatory Affairs Specialist to provide responses to regulatory agencies, direct preparation and submission of regulatory agency applications, and maintain current knowledge of relevant regulations.

Requirements

  • Bachelor’s degree or foreign equivalent in regulatory affairs, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine or a related life sciences field
  • Three years of experience in the job offered or in regulatory affairs in the pharmaceutical industry working with 505b2 and 505j FDA applications

Responsibilities

  • Provide responses to regulatory agencies regarding product information or issues
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly

Benefits

  • Annual bonus based on company performance
  • Incentive compensation program that allows you to earn more - even over plan
  • Comprehensive Health Coverage: medical, dental, vision, and prescription coverage
  • Flexibility for Your Lifestyle: hybrid work model, allowing you to work two days from home and three days in the office
  • Retirement Savings Plan (401K) that matches dollar for dollar up to 5%
  • Generous PTO policy, which offers 20 days annually + rollover (up to 40 hours)
  • 13 holidays recognized throughout the year
  • Summer-Hours perk, available between Memorial Day and Labor Day
  • Tuition reimbursement for undergraduate and graduate level courses or certifications

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