Azurity Pharmaceuticals - US

Director, Regulatory Affairs – Clinical Strategy

Raleigh, NC · Director · Full-time

Sponsorship not specifiedDetected 71 days ago

ExpressGMPFDA RegulatoryCommunicationMentoringRegulatory 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 critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports
Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

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.
Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
Bachelor's degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

Bachelor's degree in a scientific discipline or other closely related discipline is required
advanced degree preferred (MS, PharmD, PhD)

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

Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
Qualifications and Education Requirements

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.