Abbott looking for Regulatory Affairs Manager - Jobs for Degree in pharmacy, biology, chemistry, pharmacology

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Post : 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
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 28th February 2026