Associate Director Regulatory Affairs

Position Overview Full‑time Associate Director, Regulatory Affairs. Lead regulatory activities for novel biologics (large molecule/infectious disease, autoimmune disease programs) from pre‑IND/nonclinical through clinical development and marketing application. Work autonomously; support early phase interactions with regulators (FDA and/or global) and collaborate with cross‑functional teams. Essential Duties Act as Regulatory Lead for US biologics programs (infectious disease, immunological/autoimmune). Prepare/review/coordinate regulatory documentation; lead early phase meetings and IND application/IND amendments for first‑in‑human trials. Manage complex regulatory submissions (drafting, review, approvals) with cross‑functional teams and external vendors. Provide regulatory impact assessments and recommend regulatory strategy/course of action. Follow occupational health & safety procedures, GxP, and SOPs. Perform ad‑hoc regulatory work to support business initiatives. Minimum Qualifications / Skills Bachelor’s in biological-related subjects or pharmaceutical sciences. 5+ years in biologics regulatory drug development (early and late stage). Strong biology/immunology understanding; ability to rapidly learn therapeutic area and regulatory requirements. Knowledge of FDA/EU regulations and ICH. Leadership/project management experience. Direct experience writing IND/clinical trial/marketing application submission documents. Experience developing and implementing regulatory strategies. Strong planning/organizational skills and attention to detail; excellent written/verbal communication. Ability to work independently and collaborate; interact with internal/external parties; travel ~20%. Compensation & Benefits Annual base salary: $130,000–$200,000 plus target incentive. Medical/Dental/Vision; life/AD&D; short/long‑term disability; FSAs; HSA; EAP; pet insurance; 401(k) match and stock options; paid time off/sick time/holidays; career development & training. #J-18808-Ljbffr