PHARMAFull-time
Manager Regulatory Affairs
MUMBAI (IN)ONSITEPOSTED: 9/22/2026
PHARMAFull-time
HIRING ORGANIZATIONABBOTTPharmaceuticals & Healthcare
ROLE OVERVIEW
Experienced Regulatory Affairs professional responsible for product registration submissions, regulatory strategy, agency interactions, lifecycle management, and regulatory support for established pharmaceutical products.
ROLE DEFINITION & RESPONSIBILITIES
- •Direct development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports
- •Interact with regulatory agencies to support and expedite pending approvals
- •Serve as regulatory liaison throughout the product lifecycle
- •Participate in product plan development, regulatory strategy, risk management, and CMC activities
- •Support timely approval of new drugs, biologics, medical devices, and continued approval of marketed products
- •Represent Regulatory Affairs with marketing, research teams, and regulatory agencies
- •Advise development and marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory interpretations
- •Monitor regulatory developments and assess potential impact on products and business operations
Reporting Hierarchy: Reports within Abbott's Regulatory Operations organization; Works cross-functionally with development, marketing, research, manufacturing, and regulatory agency stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Experienced professional with well-developed Regulatory Affairs skills
- Strong understanding of regulatory agency processes
- Ability to manage product registration and lifecycle regulatory activities
- Strong communication and stakeholder-management capabilities
- Ability to collaborate with cross-functional teams and external stakeholders
PREFERRED QUALIFICATIONS
- •Experience with regulatory strategy, CMC, product lifecycle management, policy tracking, regulatory impact analysis, and external regulatory representation
REQUIRED VERIFIED SKILLS
Regulatory Affairs
regulatory operations
product registration
regulatory submissions
regulatory agencies
lifecycle management
regulatory strategy
CMC
risk management
technical labeling
manufacturing changes
line extensions
regulatory compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard work shift; professional development opportunities; cross-functional collaboration
The posting states the base pay as N/A and provides no explicit salary range, bonus, or equity details. No compensation figures have been inferred.
ORGANIZATION CONTEXT & CULTURE
Abbott is a global healthcare company operating across pharmaceuticals, medical devices, diagnostics, and nutrition. This role is part of Abbott's Established Pharmaceutical Products division.
TEAM SIZE: 100,000+ employees
INDUSTRY: Pharmaceuticals & Healthcare
Culture: Cross-functional regulatory collaboration, stakeholder communication, regulatory compliance, and product lifecycle support are central to the role.
EXPECTED CAREER ROADMAP
Potential progression may include Senior Manager Regulatory Affairs, Associate Director/Director Regulatory Affairs, and broader regulatory strategy or leadership positions, depending on organizational structure and experience.
APPLICATION ADVISORY
Emphasize regulatory submission and product-registration experience; highlight regulatory agency interaction and approval management; demonstrate knowledge of lifecycle management, CMC, labeling, and manufacturing changes; showcase cross-functional stakeholder management; include examples of regulatory strategy and successful submission or approval activities.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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