Assistant Manager- Regulatory Affairs in Bombay, भारत
Abbott
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
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