Director, Regulatory Affairs

Position Summary Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs provides strategic and operational leadership supporting late-stage clinical development through regulatory submission, approval, and product launch, with primary focus on FDA interactions and U.S. registration. Key Responsibilities Develop and execute regulatory strategies for biologic programs in rare disease indications (endocrinology, metabolic, oncology) and gain organizational consensus. Lead agency regulatory interactions, including preparation of IND/CTA and BLA/MAA applications and formal meetings. Pursue expedited pathways (Orphan Drug Designation, Fast Track, Breakthrough Therapy, RMAT where applicable). Provide regulatory guidance across Clinical Development, CMC, Nonclinical, and Commercial. Represent Regulatory in project team discussions; present issues and solutions. Proactively identify program-impacting issues; develop strategies and communicate to teams/management. Ensure regulatory strategy alignment with clinical development plans, including considerations for small patient populations and innovative trial designs. Identify and mitigate regulatory risks, including biologics-specific risks. Monitor regulatory trends and assess applicability. Support business development, due diligence, and investor communications with regulatory insights. Ensure compliance with applicable laws and regulations for product development and marketing. Qualifications BS/MS required; advanced degree desirable. 15+ years regulatory affairs experience in biopharmaceuticals. Significant biologics development experience, including contributions to successful BLA submissions/approvals. Experience with commercial launch regulatory activities (e.g., MLR, PRC). Technical knowledge for regulatory agency submissions. Knowledge of Clinical, Nonclinical, and CMC regulatory issues, quality systems/processes. Experience with regulatory designations (orphan, Fast Track, Breakthrough Therapy) and ex-US equivalents. Experience forming global strategy and executing with US, EU, and other ex-US authorities. Strong rare disease experience (endocrinology, metabolic disorders, and/or oncology). Demonstrated success in health authority interactions. Deep understanding of biologics CMC (manufacturing, comparability, lifecycle management). Global regulatory requirements knowledge (EMA, PMDA) is a plus. Hands-on effectiveness in small/mid-sized biotech environments. Experience managing regulatory CROs/consultants/publishers; managing personnel and setting goals. Strong analytical, communication, conflict management, negotiation, leadership, and cross-functional collaboration skills. Benefits Health Insurance (Medical/Dental/Vision); Disability, Life & Long-Term Care Insurance; Holiday Pay; Tracking Free Vacation Program; 401(k) Plan Match; Educational Assistance Benefit; Fitness Center Reimbursement. #J-18808-Ljbffr