JOB DESCRIPTION:
Core Job Responsibilities:
With Manager Oversight and Supervision:

Global Labeling Portfolio:

Develops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process. Ensures CCDS information is based on Subject Matter Expert (SME) contribution.

Organizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through.

Working with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project.

With oversight, independently completes labeling activities assigned. Assesses and approves change requests for labeling documents. Able to participate and contribute to labeling decisions within cross-functional teams.





Supervises labeling compliance of local labeling documents and reconciles deviations with company labeling documents (e.g. CCDS, corresponding patient information).

Reviews and evaluates current labeling guidelines/policy (High surveillance countries) and determines implications for company labeling documents/labeling of therapeutic area products.

Working with Product Leads and SMEs, develops strategic labeling responses, within cross-functional team at appropriate time.

GRDS Lead/Acting GRDS Lead:
Support GRDS Leads/Be a GRDS Lead to support assigned products for all non – cmc documents required by affiliates for regulatory submissions in timely manner.

File maintenance:
Maintains accurate files of labeling change history and associated documents, using the available company electronic systems.

Promotional Material Release:
• Reviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and
• Ensures that promotional materials

📌 Assistant Manager– Regulatory Affairs (Mumbai)
🏢 Abbott
📍 Mumbai