Director of Regulatory Affairs

Osprey Life Sciences, LLC is a leading consulting and services firm specializing in providing comprehensive technology solutions for Life Sciences IT organizations. Our primary focus is on assisting these organizations in effectively and efficiently delivering solutions that support their business objectives and their mission to enhance human health and improve lives. Overview Osprey Life Sciences is seeking an experienced BLA Regulatory Affairs Strategist to provide senior-level regulatory strategy and subject matter expertise in support of a Biologics License Application (BLA). This individual will help drive BLA strategy, cross-functional alignment, submission risk management, content readiness, and Health Authority meeting support. A key focus will be establishing clear, consistent regulatory messaging across submission content, including Nonclinical, Bioanalytical, CMC, and associated summary documentation. The ideal candidate has direct experience supporting late-stage development and BLA submissions and can operate independently as a strategic advisor to scientific SMEs and program leadership. Key Responsibilities Provide strategic regulatory leadership for BLA planning, development, and execution. Establish a key-message framework that ensures a clear and consistent scientific and regulatory narrative across the submission. Lead key-message development for Module 4 and Module 2.6 , including nonclinical pharmacology and toxicology. Support development of Bioanalytical (BioA) and Module 3/CMC regulatory messaging. Lead BLA gap assessments , identifying content, evidence, consistency, and submission-readiness risks. Develop mitigation strategies and drive resolution of key regulatory and submission risks. Ensure alignment across Regulatory, CMC, Nonclinical, Clinical, Safety, Bioanalytical, Medical Writing, and other functional teams. Assess submission content for consistency with overarching regulatory strategy and key messages. Support FDA and other Health Authority meetings , including meeting strategy, briefing materials, key questions, anticipated agency questions, team preparation, and follow-up. Provide senior regulatory guidance to support execution of a high-quality, scientifically consistent BLA. Qualifications Bachelor's degree in a scientific, life sciences, pharmaceutical, or related discipline; advanced degree is a plus. Significant Regulatory Affairs experience within pharmaceutical or biotechnology organizations. Demonstrated experience supporting BLA and/or NDA strategy, preparation, submission, and review . Strong understanding of FDA expectations for late-stage development and marketing applications. Experience developing regulatory strategy and key messaging across CTD submission content. Experience with Module 4/nonclinical pharmacology and toxicology and Module 2.6 strongly preferred. Demonstrated experience conducting regulatory gap assessments and managing submission risks. Direct experience supporting FDA/Health Authority interactions and meetings . Strong cross-functional leadership, communication, facilitation, and influencing skills. Ability to operate independently as a senior regulatory advisor in a fast-paced environment. Preferred Experience Experience as a Regulatory Lead, Global Regulatory Lead, Regulatory Strategy Lead, or Senior Regulatory Affairs Strategist for a late-stage program. Experience supporting a BLA through submission and FDA review. Oncology and/or biologics experience. Experience integrating regulatory messaging across Nonclinical, CMC, Clinical, and summary documentation. This role is best suited for a senior Regulatory Affairs professional who combines deep regulatory judgment with the ability to work collaboratively across scientific disciplines and drive complex submission activities toward successful execution. We offer an excellent compensation and benefits package with challenge and opportunity to learn, grow and contribute to a stimulating, fast-paced environment. Osprey is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. #J-18808-Ljbffr Osprey Life Sciences