Azurity Pharmaceuticals
Director, Regulatory Affairs – Clinical Strategy
Azurity Pharmaceuticals, Woburn, Massachusetts, us, 01813
Director, Regulatory Affairs – Clinical Strategy
Woburn, MA 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.
Overview
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.
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 mitigation strategies
Interact with and support the Azurity Clinical Development and Medical 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)
#LI-Hybrid
Benefits We Offer
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions.
Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
Voluntary Self-Identification Azurity Pharmaceuticals - US has my consent to collect, store, and process my data for the purpose of considering me for employment, and for up to 60 days thereafter.
Public burden and disability information are provided as part of voluntary self-identification forms and government compliance materials. This content is retained for regulatory purposes and is not a required component of the job description itself.
#J-18808-Ljbffr
Woburn, MA 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.
Overview
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.
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 mitigation strategies
Interact with and support the Azurity Clinical Development and Medical 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)
#LI-Hybrid
Benefits We Offer
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions.
Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here.
The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
Voluntary Self-Identification Azurity Pharmaceuticals - US has my consent to collect, store, and process my data for the purpose of considering me for employment, and for up to 60 days thereafter.
Public burden and disability information are provided as part of voluntary self-identification forms and government compliance materials. This content is retained for regulatory purposes and is not a required component of the job description itself.
#J-18808-Ljbffr