Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Job Summary As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, reviewing, and submitting regulatory filings to the FDA and other global health agencies. The person will play a crucial role in managing the lifecycle of IND, NDA, ANDA, etc., and will report to the Associate Director, Regulatory Affairs. The position works cross‑functionally with teams including Technical Operations, Quality Assurance, Clinical Development, and Medical Affairs. Responsibilities Provide regulatory assistance with due diligence requests to support new business development activities. Support interaction with FDA and other regulatory agencies for assigned commercial products. Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post‑marketing supplements for assigned products. Manage the timelines associated with regulatory submissions such as post‑marketing periodic reports. Manage archival of regulatory submissions, regulatory correspondence, and associated logs and tracking mechanisms. Provide regulatory guidance on requirements for post‑approval changes, as required, for assigned products. Review and provide regulatory assessments for change control documentation. Provide regulatory support to regulatory leadership meetings and presentations. Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes. Participate in activities of setting goals, tracking deliverables, and process improvements within the regulatory department. Other duties as assigned. Qualifications Minimum of a Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification. Minimum of 3 years in the pharmaceutical industry with at least 1 year in regulatory affairs. Combination of education and applicable job experience may be considered. Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required. Ability to work independently with minimal supervision in a fast‑paced, deadline‑driven environment. Keen attention to detail. Ability to rapidly adapt to changing environments and circumstances requiring flexibility, tolerance, and a sense of urgency while ensuring that all cGMP and regulatory requirements are met. Ability to successfully communicate, negotiate, and influence regulatory strategy to key stakeholders. Physical & Mental Requirements 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 a keyboard, operate a telephone, and hand‑held devices. Other miscellaneous job duties as required. Benefits Unlock Your Earning Potential: Competitive compensation package, including an annual bonus based on company performance. Sales compensation: In lieu of annual bonuses, an incentive compensation program allows sales personnel to earn more, even over plan. Fuel Your Success: Car reimbursement program and gas card for both business and personal use (sales only). Comprehensive Health Coverage: Medical, dental, vision, and prescription coverage for you and your family. Flexibility: Hybrid work model—two days from home and three days in the office (excludes sales, manufacturing, and some operations positions). Retirement Savings Plan: 401(k) with dollar‑for‑dollar match up to 5%. Time Off: Up to 15 vacation days annually plus rollover (up to 40 hours) and five sick/wellness days; new employees accrue vacation prorated based on start date. Holiday Schedule: Company closes between Christmas and New Year’s for an extra week off; 13 holidays recognized annually. Professional Development: Tuition reimbursement for undergraduate and graduate level courses or certifications. Recognition: High Five peer recognition platform to celebrate accomplishments. #J-18808-Ljbffr