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 submission materials, developing regulatory strategies, and staying current on regulations. This remote position offers a hybrid work option in select locations. The role requires a Bachelor's degree in a related life sciences field and three years of relevant experience. Azurity offers a competitive compensation package, including an annual bonus, comprehensive health coverage, a hybrid work model, and various other benefits.

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
• Travel: The position requires travel to client sites or Azurity Pharmaceutical’s other offices nationwide once per year for two to three days
• Hours: 40/week, 9:00 a.m. – 5:00 p.m
• Location: Remote work nationwide with the option to work at one of the company’s offices noted below (Raleigh, Woburn and Atlanta) on a hybrid schedule (3 days in the office and 2 days remote)
• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required

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 that allows you to earn more - even over plan
• 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, where you can enjoy a fresh bagel on us every Tuesday morning
• 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
• We close between Christmas and New Year’s to give you an 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 allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work