Assistant Manager- Regulatory Affairs in Bombay, भारत

Abbott seeks an Assistant Manager in Regulatory Affairs to manage global labeling portfolios, maintain compliance documentation, and support product registrations across international markets. The role involves developing core data sheets, coordinating with cross-functional teams, and providing regulatory guidance to affiliates from the Mumbai office.

Responsibilities

• Develop and maintain Company Core Data Sheets and Master Package Leaflets aligned with scientific evidence and regulatory requirements
• Supervise labeling compliance of local documents and reconcile deviations with global standards
• Review and assess new labeling guidelines from high-surveillance countries for impact on company products
• Support affiliate labeling needs including renewals, geographic expansions, and license maintenance activities
• Coordinate preparation of regulatory modules and periodic safety reports for affiliate submissions

Requirements

• Bachelor's degree in Pharmacy or life science discipline
• 5-7 years pharmaceutical industry experience in regulatory affairs, labeling, or related functions
• Fluent spoken and written English
• Advanced proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Strong interpersonal skills for global team collaboration
• Meticulous attention to detail
• Diploma in Regulatory Affairs (preferred)