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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

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• 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
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• 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)

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