Regulatory Affairs Manager - US Regulatory Lead, Rare Disease
Core
Ensure compliance with US regulations and laws for Amgen's products, specifically in the Rare Disease therapeutic area, by managing regulatory strategies and submissions.
Role type
Senior Regulatory Affairs Manager (US Regulatory Lead)
Builds
Regulatory strategies, IND submissions, and compliance documentation for Rare Disease products.
Domain
Biotechnology / Rare Disease
Required skills
Regulatory strategy planning, agency correspondence, submission management, label development, compliance monitoring, global regulatory plan support, documentation authorship
Preferred skills
Biology or life science background, regulated industry experience, organizational skills
Technologies
Regulatory submission systems, labeling tools
Responsibilities
Support Global Regulatory Team in US activities (IND development), act as point of contact with regulatory agencies, plan and manage local regulatory submissions, ensure product compliance and label maintenance, provide input into global regulatory strategy, prepare supportive documentation for regulatory deliverables, author routine regulatory correspondence