Senior Manager, Global Clinical Regulatory Lead

Role: Senior Manager, Global Clinical Regulatory Lead, overseeing strategic and operational regulatory activities for PTC's drug products in the US and globally. Primary objectives include managing IND submissions, clinical trial applications, and supporting product life cycle regulatory strategies aligned with regional and international requirements. Responsibilities encompass collaboration with cross-functional teams, conducting regulatory research, preparing and reviewing submissions (e.g., IND, NDA, BLA, Orphan/ Pediatric Designations), and ensuring compliance with applicable regulations and standards. The role also supports pharmacovigilance activities and interacts with external agencies and CROs on clinical trial initiations and interactions. Qualifications: Bachelor's in life sciences with 5+ years in pharma/biotech, or MS/PhD/PharmD with at least 3 years in Regulatory Affairs. Demonstrated experience managing clinical trial applications and regulatory submissions across phases, with knowledge of US, EU, and global regulatory guidelines. Strong communication, stakeholder management, and independent working skills are critical. High-Value: Involves biologics, gene therapies, or small molecules within clinical development stages, supporting IND/CTA filings, and working in a hybrid NJ role with up to 5% travel.