Macleods Walk-in Regulatory Affairs

MPharm Regulatory Affairs Jobs Macleods Mumbai Walk-In

Macleods hiring Regulatory Affairs roles in Mumbai. MPharm, BPharm, MSc with 2–15 yrs experience. Walk-in on 18 April.

Macleods Pharmaceuticals is conducting a walk-in drive for multiple vacancies in the Regulatory Affairs department at its R&D center in Mumbai. The company is hiring experienced professionals for roles including Officer, Executive, and Assistant Manager, specifically for the US regulatory market. This is a strong opportunity for candidates with 2 to 15 years of experience in pharmaceutical regulatory affairs, particularly those involved in ANDA submissions and compliance with USFDA guidelines.

The hiring is focused on professionals who have hands-on experience in preparing and submitting regulatory dossiers, managing documentation, and staying updated with evolving global regulatory requirements. Candidates from M.Pharm, B.Pharm, and M.Sc backgrounds with exposure to solid oral dosage forms, injectables, or MDI products will find this role highly aligned with long-term career growth in regulatory affairs and global pharma compliance.

Company Overview

Macleods Pharmaceuticals is one of India’s leading pharmaceutical companies with a strong presence in global markets, particularly in regulated regions like the United States. The company is known for its focus on research-driven development, high-quality generic formulations, and compliance with international regulatory standards.

With advanced R&D facilities and a strong pipeline of products, Macleods plays a key role in delivering affordable healthcare solutions worldwide. The organization emphasizes regulatory excellence, innovation, and continuous improvement, making it a preferred workplace for professionals in regulatory affairs and pharmaceutical development.

Working at Macleods offers exposure to USFDA regulations, ANDA filing processes, and global pharmaceutical compliance systems.

Job Role & Responsibilities

Regulatory Affairs – US Market

• Prepare and compile regulatory dossiers including ANDA submissions
• Review and update regulatory documentation as per USFDA guidelines
• Ensure compliance with current regulatory requirements for solid oral, injectable, and MDI products
• Coordinate with cross-functional teams including R&D, QA, and production
• Track regulatory changes and implement updates in submission strategies
• Respond to queries and deficiencies from regulatory authorities
• Maintain lifecycle management of regulatory submissions

This role is critical in ensuring timely product approvals, regulatory compliance, and successful entry into global pharmaceutical markets.

Eligibility / Qualifications

Candidates must have completed:

M.Pharm, B.Pharm, M.Sc

Relevant courses include: Pharmaceutical Regulatory Affairs, Industrial Pharmacy, Pharmaceutics, Organic Chemistry, Quality Assurance, Drug Regulatory Affairs, Clinical Research

• Experience: 2 to 15 years in pharmaceutical regulatory affairs
• Strong experience in ANDA submissions and USFDA requirements
• Knowledge of regulatory documentation for solid oral, injectables, and MDI
• Good understanding of changing global regulatory guidelines
• Strong communication and documentation skills required

Location & Salary

• Job Location: Macleods R&D Centre, Andheri East, Mumbai
• Walk-In Date: 18 April 2026
• Time: 09:00 AM onwards
• Salary: Competitive and based on experience and role

Application Process

Candidates can attend the walk-in interview directly at the venue:

Venue:
Plot 60, Street No. 14, MIDC Phase II
Andheri East, Mumbai – 400093

Documents Required:

• Updated CV
• Salary structure (CTC breakup)
• Aadhaar card

Contact Details:

• Phone: 7208877803 / 8291054728

Important Instructions:

• Candidates must carry all required documents
• Experience in US regulatory market is essential
• Be prepared for technical discussions on ANDA and USFDA guidelines

Why This Opportunity Stands Out

• Work with a leading global pharmaceutical company
• Direct exposure to USFDA regulatory environment
• Opportunity to handle ANDA submissions and lifecycle management
• Strong career growth in regulatory affairs and global compliance
• Work in advanced R&D setup with cross-functional exposure

FAQs

Who can apply for this role?
Candidates with M.Pharm, B.Pharm, or M.Sc and relevant experience.

Is USFDA experience required?
Yes, experience in US regulatory affairs and ANDA submissions is required.

What positions are available?
Officer, Executive, and Assistant Manager.

What is the experience range?
2 to 15 years.

How to apply?
Attend the walk-in interview with required documents.

Summary Table

Category	Details
Company	Macleods Pharmaceuticals
Vacancies	Officer, Executive, Assistant Manager (Regulatory Affairs)
Required Education	M.Pharm, B.Pharm, M.Sc
Experience	2 to 15 Years