Azurity Pharmaceuticals · 7 hours ago
Director, Regulatory Affairs – Clinical Strategy
Woburn, MA
Full-time
Hybrid
Director/Executive
10+ years expAzurity Pharmaceuticals is a privately held specialty pharmaceutical company focused on innovative products for underserved patients. The Regulatory Affairs Director – Clinical Strategy will develop and implement clinical regulatory strategies, ensuring compliance with health authority requirements, and will collaborate cross-functionally to support drug development and regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceutical
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
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
Qualification
Required
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)
Benefits
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.
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.
Company
Azurity Pharmaceuticals
Azurity Pharmaceuticals is a developer of drug products and technologies to address the needs of patients.
501-1000 employees
H1B Sponsorship
Azurity Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (4)
Funding
Current Stage
Late StageTotal Funding
$20MKey Investors
Ampersand Capital Partners
2018-03-26Acquired
2015-01-06Private Equity
2014-12-30Series Unknown· $20M
Leadership Team
Vinicius de Lima
Chief Medical Officer
Recent News
Azurity Pharmaceuticals
2025-11-18
Company data provided by crunchbase