Senior Manager of Regulatory Affairs

Summary

Join Azurity Pharmaceuticals, a specialty pharmaceutical company, and contribute to the development and regulatory compliance of innovative products. You will be responsible for responding to regulatory agencies, preparing and submitting applications, reviewing materials for accuracy and compliance, and developing regulatory strategies. The role requires a Bachelor’s degree in a related life sciences field and three years of relevant experience. The position offers a remote work option nationwide with the possibility of a hybrid schedule in select offices. Azurity provides a competitive compensation package, including an annual bonus, comprehensive health coverage, and a generous time off policy. Additional benefits include a retirement savings plan, tuition reimbursement, and various employee perks.

Requirements

Bachelor’s degree or foreign equivalent in regulatory affairs, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine or a related life sciences field, plus 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

• Competitive compensation package, including an annual bonus based on company performance
• Incentive compensation program
• Car reimbursement program and gas card for both business and personal use
• Excellent medical, dental, vision, and prescription coverage
• Hybrid work model, allowing you to work two days from home and three days in the office
• ���Bagel Tuesday” perk
• Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%
• Generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days
• Extra week off to spend quality time with your family and recharge
• Over the course of the year, Azurity recognizes 13 holidays
• Summer-Hours perk, available between Memorial Day and Labor Day
• Tuition reimbursement for undergraduate and graduate level courses or certifications
• Azurity High Five peer recognition platform