PHARMAFull-time
Manager - Regulatory Affairs
By Admin · Regulatory Affairs
MUMBAI (IN)ONSITEPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONABBOTTPharmaceuticals & Healthcare
ROLE OVERVIEW
Manage Regulatory CMC activities for assigned products, including registrations, submissions, lifecycle compliance, regulatory strategy, health-agency interaction and cross-functional coordination within Abbott's Established Pharmaceutical Products division.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead product registrations and prepare documentation for complex and routine regulatory filings
- •Manage project activities, timelines and regulatory submission deliverables
- •Prepare responses to deficiency letters and coordinate required technical information
- •Represent Regulatory CMC in project meetings and communicate regulatory positions
- •Monitor regulatory activities, risks, issues and timelines across cross-functional teams
- •Develop Regulatory CMC strategies and support lifecycle compliance and change requests
- •Coordinate with regional product leads and affiliates
- •Support health-agency meetings, licensing reviews and due-diligence activities
Reporting Hierarchy: Reports within the Regulatory Affairs organization; collaborates with cross-functional project teams, regional product leads, affiliate colleagues and health agencies
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related subject
- Minimum 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas
- Knowledge of global and regional regulatory requirements
- Specialist knowledge of assigned country or product-class requirements
- Regulatory CMC experience
- Strong project management and cross-functional collaboration skills
PREFERRED QUALIFICATIONS
- •Experience with complex product registrations and CMC submissions
- •Health-agency interaction experience
- •Due-diligence or licensing review experience
- •Experience mentoring and training junior regulatory professionals
REQUIRED VERIFIED SKILLS
Regulatory CMC
product registration
regulatory submissions
lifecycle management
regulatory strategy
regulatory compliance
health agency interaction
CMC documentation
deficiency responses
project management
risk management
global regulatory requirements
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard corporate benefits, employee support programs and professional development opportunities
The posting states base pay as N/A and provides no numerical salary range. Compensation should therefore be based on the official Abbott offer and applicable location-specific compensation information.
ORGANIZATION CONTEXT & CULTURE
Abbott is a global healthcare company developing and manufacturing products across pharmaceuticals, medical devices, diagnostics and nutrition.
TEAM SIZE: 100,000+ employees
INDUSTRY: Pharmaceuticals & Healthcare
Culture: The role emphasizes integrity, teamwork, initiative, adaptability, innovation, knowledge sharing and results-oriented leadership.
EXPECTED CAREER ROADMAP
Potential progression includes senior Regulatory Affairs leadership, Regulatory CMC strategy roles, regional regulatory leadership or broader regulatory operations management through increasing product, market and team responsibility.
APPLICATION ADVISORY
Highlight 10+ years of Regulatory Affairs/R&D/Manufacturing experience; emphasize CMC submissions and product-registration expertise; demonstrate knowledge of Indian and global regulatory requirements; include examples of regulatory strategy, risk mitigation and health-agency interaction; show leadership, mentoring and cross-functional project experience.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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