Director, Regulatory Affairs – Clinical Strategy

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)