Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals - US • Raleigh, NC

2d • Hybrid

About The Position

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. For more information, visit www.azurity.com.
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.
Brief 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.

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.

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.

Benefits

• Competitive compensation package
• Annual bonus based on company performance
• Incentive compensation program (Sales Only)
• Car reimbursement program (Sales Only)
• Gas card (Sales Only)
• Medical coverage
• Dental coverage
• Vision coverage
• Prescription coverage
• Hybrid work model
• Retirement Savings Plan (401K)
• 401K matching dollar for dollar up to 5%
• Up to 15 vacation days annually + rollover (up to 40 hours)
• Five sick/wellness days
• Company closure between Christmas and New Year's
• 13 holidays recognized
• Tuition reimbursement for undergraduate and graduate level courses or certifications
• Azurity High Five peer recognition platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level