Macleods Pharmaceuticals Hiring For Regulatory Affairs

Macleods Pharmaceuticals is conducting a walk-in drive in Mumbai for multiple positions including Officer, Executive, and Assistant Manager roles in the R&D Regulatory Affairs department.

This is an excellent opportunity for professionals with experience in ANDA submissions, USFDA regulatory requirements, and pharmaceutical documentation to work with one of India’s leading pharma companies.

Job Overview

• Company: Macleods Pharmaceuticals
• Department: Regulatory Affairs (R&D)
• Position: Officer / Executive / Assistant Manager
• Location: Mumbai (Andheri East – MIDC Phase II)
• Market: US (USFDA)
• Qualification: M.Pharm / B.Pharm / M.Sc
• Experience: 2 to 15 Years

Key Responsibilities

• Preparation and submission of regulatory documents to global authorities
• Compilation and review of ANDA modules (CTD/eCTD)
• Handling USFDA regulatory requirements for:
  • Solid Oral Dosage (OSD)
  • Injectables
  • Metered Dose Inhalers (MDI)
• Monitoring regulatory updates and compliance changes
• Coordination with cross-functional teams (R&D, QA, Production)
• Ensuring accuracy, completeness, and timely submission of dossiers

Eligibility Criteria

• Educational Qualification:
  • M.Pharm / B.Pharm / M.Sc (Life Sciences, Chemistry, Pharmacy)
• Experience Required:
  • 2–15 years in Pharmaceutical Regulatory Affairs
  • Strong knowledge of ANDA submission & USFDA guidelines
  • Hands-on experience in CTD/eCTD documentation

Preferred Skills

• Expertise in Regulatory Affairs for US market
• Knowledge of FDA requirements for OSD, Injectables & MDI
• Strong documentation and analytical skills
• Familiarity with global regulatory frameworks

Benefits of Joining Macleods

• Opportunity to work on USFDA regulatory submissions
• Exposure to global pharmaceutical markets
• Career growth in R&D Regulatory Affairs
• Work with an established pharma leader in India
• Competitive salary and learning environment

Walk-In Interview Details

• Date: 18th April 2026
• Time: 09:00 AM onwards
• Venue:
  Plot No. 60, Street No. 14,
  MIDC Phase II, Andheri East,
  Mumbai – 400093
• Contact Numbers:
  7208877803 / 8291054728

Documents to Carry

• Updated Resume (CV)
• Salary Structure (CTC breakup)
• Aadhaar Card

How to Apply

Interested candidates can directly attend the walk-in interview at Macleods Mumbai R&D center on the scheduled date and time. Ensure you carry all required documents for a smooth interview process.