Assistant Manager– Regulatory Affairs

About the role

Assistant Manager– Regulatory Affairs at Abbott. With Manager Oversight and Supervision.

What you'll do

• 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
• With oversight, independently completes labeling activities assigned. Assesses and approves change requests for labeling documents. Able to participate and contribute to…
• Supervises labeling compliance of local labeling documents and reconciles deviations with company labeling documents (e.g. CCDS, corresponding patient information)

What you need

• 5–7 yrs of experience
• Regulatory affairs
• Documentation
• PowerPoint
• Diploma