Description
The Regulatory Manager provides regulatory development advice and guidance throughout the clinical development life cycle, coordinates and prepares regulatory submissions for regulatory authorities and ethics committees, and supports Precision for Medicines’ corporate regulatory function. The role includes reviewing applications such as CTA/INDs, annual reports, amendments, scientific advice, orphan designations, pediatric planning, and marketing applications; leading regional or global projects; overseeing Regulatory Affairs Specialists; developing regulatory strategy and timelines; and providing ICH GCP guidance and training. The position requires a bachelor’s degree or equivalent experience, fluent English, computer literacy, and at least five years of relevant regulatory affairs experience, with specialization in at least one major region. It is a remote role with domestic and international travel, a base salary of $106,000–$151,000 USD, and eligibility for a discretionary annual bonus and other benefits.
