Senior Manager of Regulatory Affairs

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