Assistant Manager -Regulatory Affairs
Core
Develops and maintains global labeling documents (Core Data Sheets, Patient Information Leaflets) and supports regulatory submissions for pharmaceutical products.
Role type
Assistant Manager, Regulatory Affairs (Global Labeling)
Builds
Global labeling documentation and regulatory submission packages for therapeutic area products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory guidelines knowledge, labeling document development, cross-functional collaboration, change request assessment, file maintenance, promotional material compliance review, stakeholder education, Module 2/4/5 preparation, periodic report coordination
Preferred skills
Hands-on experience with labeling texts for health professionals and patients, Diploma in Regulatory Affairs
Technologies
Microsoft Office (Word, Excel, PowerPoint), company electronic systems
Responsibilities
Develops and maintains Core Data Sheets and Patient Information Leaflets based on scientific knowledge and guidelines; Organizes Labeling Sub-Team meetings; Assesses and approves change requests for labeling documents; Supervises labeling compliance of local documents; Reviews new labeling guidelines for high surveillance countries; Supports regulatory submissions (Module 2, 4, 5) and periodic reports (RMP, PSURs, ACOs); Reviews and approves promotional materials for compliance; Provides labeling support to affiliates for renewals and expansions.
Seniority
Mid-level Manager, hands-on IC