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Manager / Senior Manager – Regulatory Affairs

Abbott
Abbott
8-15 years
Not Disclosed
Mumbai, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill

Manager / Senior Manager – Regulatory Affairs Job in Mumbai, India

Company: Abbott Laboratories
Job Title: Manager / Senior Manager – Regulatory Affairs
Location: Mumbai, India
Department: Regulatory Affairs
Industry: Pharmaceutical / Biologics / Biosimilars
Job Type: Full-Time


About Abbott

Abbott is a leading global healthcare company focused on delivering innovative medicines, diagnostics, nutrition products, and medical technologies. With a strong commitment to scientific advancement and healthcare innovation, Abbott continues to expand its pharmaceutical and regulatory operations across global markets.

The company provides excellent career growth opportunities, international exposure, and a collaborative work environment for professionals in regulatory affairs, clinical development, and pharmaceutical operations.


Job Overview

Abbott is hiring an experienced Manager / Senior Manager – Regulatory Affairs to join its Regulatory Affairs team in Mumbai, India. The role involves leading regulatory strategy development, managing new product registrations, coordinating with regulatory authorities, and ensuring compliance for pharmaceutical, biologics, and biosimilar product approvals.

The selected candidate will be responsible for end-to-end regulatory submissions, regulatory pathway planning, dossier management, SEC coordination, and product launch support while collaborating closely with cross-functional teams including R&D, Quality, Medical Affairs, Clinical, Supply Chain, and Project Management.

This position is ideal for senior regulatory professionals with strong expertise in CDSCO submissions, SUGAM portal filings, new product approvals, and Indian pharmaceutical regulations.


Experience Required

Experience Level

  • Mid-Level to Senior-Level Regulatory Affairs Professional
  • Freshers are not eligible

Required Experience

  • Minimum 8–15 years of experience in:
    • Regulatory Affairs
    • Pharmaceutical Product Registration
    • CDSCO Submissions
    • New Product Filings
    • Biologics & Biosimilars Regulatory Operations
    • Drug Approval Processes

Preferred Experience

  • FSSAI Regulatory Experience
  • SEC Meeting Coordination
  • SUGAM Portal Filing
  • ND / SND / FDC Applications
  • Import Registration & Import License Applications

Educational Qualification

Required Qualification

Candidates must possess:

  • M.Pharm
    or
  • B.Pharm