Associate Specialist, Regulatory Affairs
Core
Supports the submission and maintenance of Marketing Authorization applications for pharmaceutical products, ensuring regulatory compliance and managing documentation.
Role type
Associate Specialist, Regulatory Affairs
Builds
Marketing Authorization applications, regulatory filings, and compliance documentation
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory Applications, Regulatory Compliance, Document Control Systems, eCTD, Adverse Event Reporting, Artwork Management, Data Quality Assurance, Records Retention Management, Policy Implementation, Regulatory Communications
Preferred skills
None stated
Technologies
eCTD, Document Control Systems
Responsibilities
Perform timely submissions of new Marketing Authorization applications; maintain marketing authorizations through variations and renewals; build and maintain Regulatory Official Files; assist in preparation, translation, and quality assurance of submission documents; develop and proofread packaging artwork and labels; participate in establishing Standard Operating Procedures.
Seniority
Associate (Under supervision)
