Azurity Pharmaceuticals - US

Regulatory Affairs Associate/Senior Associate

Raleigh, NC · Senior · Full-time

Sponsorship not specifiedDetected 16 days ago

ComplianceBusiness DevelopmentGMPFDA RegulatoryLeadershipCommunicationMicrosoft OfficeRegulatory Affairs

About the role

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients.
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.

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.
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 support to regulatory leadership meetings and presentations.
Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

Must be able to sit for long periods of time
While performing the duties of this job, the employee is frequently required to stand
Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required
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.
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.

In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.

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.
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.
Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
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.
Qualifications and Education Requirements
We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.

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.
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.

This listing is sourced directly from Azurity Pharmaceuticals - US's careers page and normalized into a canonical job model.