Regulatory Affairs Associate/Senior Associate

Regulatory Affairs Associate/Senior Associate

Raleigh, NC

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Team/Department Description

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies. The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Principle 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 various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
• Other duties as assigned.

Qualifications and Education Requirements

• Minimum of 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 of those years 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 environment and circumstances requiring flexibility, tolerance and great 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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

Benefits We Offer:

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
• Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
• Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. * Excludes Sales, Manufacturing, and some Operations positions*
• Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
• Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
• Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
• Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
• Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
• Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.