What are the responsibilities and job description for the Director, Regulatory Affairs - Clinical Regulatory Strategy position at Azurity Pharmaceuticals - US?
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.
As a part of the Regulatory Affairs team at Azurity, this Regulatory Director will conduct in depth analysis of regulatory and clinical information to determine the best regulatory and clinical pathway and strategy for potential drug products for development of the Azurity portfolio of medications. The Regulatory Director will report to the Vice President of Regulatory Affairs and work cross-functionally with other Azurity teams determining regulatory strategy including but not limited to Franchise Managers, Clinical Development, and Product Development. This person will play a critical role by providing the regulatory and clinical strategy for new products in development and potential new indications for approved products. The Regulatory Director will also direct the activities of Advertising / Promotional Review Teams. They will be responsible for providing Advertising / Promotional regulatory insight in line with applicable regulatory guidelines and will serve as a liaison and subject matter expert (SMA) on the interpretation of US Advertising / Promotional FDA guidance documents and regulations.
Responsibilities : Strategy :
- 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 clinical and regulatory requirements.
- Knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics.
- Assessment of regulatory and clinical critical approval factors, including but not limited to, PK, PREA, and other post-marketing safety studies.
- Assessment of current regulatory pathways within relevant therapeutic areas to provide insight on potential future development opportunities to build the R&D pipeline.
- 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.
- Experience with preparation of initial pediatric study plans and non-clinical and clinical sections in support of 505(b)(2) NDA submissions.
- Direct interaction and liaison with regulatory agencies as required.
Advertising / Promotional :
Preferred Qualifications :
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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