Manager, Regional Regulatory Lead - LCM

Role: Regional Regulatory Affairs Lead responsible for developing and executing global regulatory strategies for assigned biopharma products, ensuring timely regulatory approvals and positive health authority relationships. Responsibilities include managing product-specific interactions with FDA or EMA, supporting regulatory filings, developing local knowledge of regulatory requirements, and collaborating with GRAST and commercial teams to align strategies and deliverables. The role also involves preparing core regulatory documentation, contributing to strategic discussions, and maintaining regulatory systems. Requirements: Bachelor's in life sciences (Pharmacy, Biology, Chemistry, etc.), 5+ years of biotech/pharma regulatory experience, including 3+ years on developmental products; knowledge of US, EU, Japan regions; experience with agency interactions preferred. Advanced degrees (MS, PhD, MD) or MBA are advantageous. High-Value: Biotech/pharma, regulatory strategy, product development, US/EMA/Japan regulations, regulatory submissions, GxP, cross-functional collaboration. Work setup: Hybrid in Waltham, MA or King of Prussia, PA, with at least 3 days onsite weekly. Travel not specified.