Director, Regulatory Affairs - Clinical Strategy

Job Description

Job Description

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 a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities. The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

Principle Responsibilities :

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD) / real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• 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
• Preparation and presentation of research data and findings on clinical / regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate / lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• 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

CORE Responsibilities

Qualifications and Education Requirements

#LI-Hybrid

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.

Benefits We Offer :

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

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