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Senior Regulatory Affairs Manager, India & Saarc

7-13 years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Regulatory Affairs Manager – India & SAARC

Location: Gurgaon, India
Work Mode: On-site


Job Summary

Abbott is seeking a highly experienced Senior Regulatory Affairs Manager for its India & SAARC operations, based in Gurgaon. This is a specialist-level role for a regulatory affairs expert with deep knowledge in product registration, regulatory submissions, lifecycle management, and cross-functional strategy. The ideal candidate will drive the success of regional regulatory initiatives across the pharmaceutical, medical device, and biologics portfolio.


Key Responsibilities

  • Direct and manage regulatory submissions including registration, supplements, and periodic reports.

  • Serve as primary liaison with regulatory authorities for new product approvals and lifecycle support.

  • Contribute to regulatory strategy, risk management, and CMC-related activities.

  • Ensure timely and compliant approval of new drugs, biologics, and devices.

  • Advise cross-functional teams on labeling, manufacturing changes, and regulatory interpretations.

  • Support marketing and research teams with regulatory insights and solutions.


Required Skills & Qualifications

  • Minimum 7 years of experience in Regulatory Affairs within pharmaceuticals, biologics, or medical devices.

  • Associate’s Degree or higher in a relevant scientific field.

  • Proven expertise in product registration and regulatory submissions.

  • Deep understanding of CMC, GxP regulations, and global health authority expectations.

  • Ability to communicate effectively with internal teams and regulatory agencies.

  • Strategic mindset with attention to compliance and timelines.


Perks & Benefits

  • Competitive compensation and benefits package

  • Global exposure in a reputed healthcare MNC

  • Career growth within a high-impact regulatory function

  • Opportunity to work on diverse therapeutic portfolios

  • Dynamic and inclusive workplace culture


About the Company

Abbott is a global healthcare leader that develops innovative pharmaceuticals, medical devices, and diagnostics solutions. With a strong presence in India and SAARC, Abbott is committed to delivering science-based solutions that advance health and improve lives.


Call to Action

Ready to make a regulatory impact in a global organization? Apply now to join Abbott as a Senior Regulatory Affairs Manager in Gurgaon and shape healthcare across India and SAARC.