Manager, Regulatory Affairs
Core
Independently manage regulatory projects for pipeline and registered pharmaceutical products, including CTA, NDA, Renewal, and Variations, while interacting with global regulatory agencies.
Role type
Manager, Pharmaceutical Regulatory Affairs
Builds
Registration dossiers and responses for regulatory agencies (CDE, etc.)
Domain
Pharmaceutical industry, Regulatory Affairs
Required skills
Pharmaceutical Regulatory Affairs, Project Management, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Global Communications, Detail-Oriented
Preferred skills
Ophthalmology product experience
Technologies
EXCEL, POWERPOINT, WORD
Responsibilities
Prepare registration dossiers and respond to agency questions, organize CDE interactions (Pre-IND, Pre-NDA), follow registration procedures, obtain final registration permits, support strategic planning for products
Seniority
Manager, hands-on leadership