Website Abbott India Ltd
Post Name: Regulatory Affairs Manager
Job Description:
1. Product registrations / Submissions
• Actively leads product registrations by preparing/ requesting documentation needed for complex filings
• Employs project management skills to monitor activities and meet deadlines
• Prepares registration packages for routine filings
• Identifies and collects data needed
• Seeks expert advice and technical support for complex filings
• Prepares responses to deficiency letters
2. Relationships & Cross Functional team work
• Represents Regulatory CMC at relevant project meetings and communicates agreed RA position
• Monitors and communicates actual versus planned regulatory activities and timelines
• Identifies and communicates risks and issues impacting project progression
3. Affiliate Coordination
• Maintains strong working relationships with Regional Product Leads and Affiliate colleagues
4. Compliance across Life Cycle
• Assesses and approves change requests and updates files accordingly
• Maintains awareness of legislation and current developments within specific area of business
• Works to assure products remain in compliance
5. Strategy
• Develops Regulatory CMC strategies for assigned products and projects
• Identifies, communicates, and mitigates Regulatory CMC risks
6. Process Improvement
• Identifies opportunities and suggests improvements
• Supports the development of position papers & work aids etc
7. Health Agency Interaction
• Attends Health Agency meetings as appropriate
8. Licensing Reviews
• Provides CMC Regulatory support for due diligence activities
9. Technical competency
• Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products
• Has general knowledge of global and regional regulatory requirements
• Has specialist regulatory knowledge of assigned country or product class requirements
Candidate Profile:
Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject
A mznimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas
Additional Information:
Experience : Minimum 10 years
Qualification : Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 28th February 2026
