Looking for Regulatory Affairs jobs in Mumbai? Macleods Pharmaceuticals is conducting a Walk-in Drive on 18 April 2026 for Officer / Executive / Assistant Manager positions in the Regulatory Affairs (US Market) department at its R&D centre in Andheri East, Mumbai.
This is an excellent opportunity for candidates with 2–15 years of experience in pharmaceutical regulatory affairs, especially for ANDA submissions to the US FDA.
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About the Company
Macleods Pharmaceuticals is a fast-growing, research-driven Indian pharmaceutical company with a strong global presence. The company specializes in developing and manufacturing high-quality generic medicines across multiple dosage forms including solid orals, injectables, and Metered Dose Inhalers (MDI).
With a robust R&D setup and focus on regulated markets like the US, Macleods offers excellent career growth in regulatory affairs.
Job Details
- Company Name: Macleods Pharmaceuticals
- Department: Regulatory Affairs (US Market)
- Position: Officer / Executive / Assistant Manager
- Location: R&D Plot 60, Andheri East, Mumbai
- Qualification: M.Pharm / M.Sc / B.Pharm
- Experience: 2 to 15 years
- Walk-in Date: 18 April 2026 (Saturday)
- Time: 09:00 AM onwards
Job Description
Macleods is hiring experienced professionals for its US Regulatory Affairs team. The role involves preparation and submission of regulatory documentation to the US FDA, compilation of ANDA modules, and handling post-approval changes for solid oral, injectable, and MDI products.
Key Responsibilities
- Prepare and submit regulatory dossiers (ANDA modules) to US FDA
- Handle post-approval changes, variations, and supplements
- Compile original ANDA submissions for solid oral, injectable, and MDI products
- Keep track of changing FDA requirements and guidelines
- Coordinate with cross-functional teams (R&D, QA, Production) for timely submissions
- Respond to FDA queries and deficiencies
Skills/Qualifications
- M.Pharm / M.Sc / B.Pharm qualification
- 2–15 years of experience in Pharmaceutical Regulatory Affairs (US Market)
- Strong knowledge of ANDA submission process and FDA regulations
- Experience in compiling modules for solid oral, injectable, or MDI products
- Understanding of current FDA guidelines and requirements
- Excellent documentation and communication skills
- Ability to work independently and manage multiple submissions
Benefits/Perks
- Opportunity to work with a leading Indian pharma company
- Exposure to US FDA-regulated submissions (solid oral, injectable & MDI)
- Career growth in Regulatory Affairs at Officer to Assistant Manager level
- Work in a modern R&D facility in Mumbai
How to Apply
Walk-in Interview Details
- Date: 18 April 2026 (Saturday)
- Time: 09:00 AM onwards
- Venue: Plot 60, Street No. 14, MIDC Phase II, Andheri East, Mumbai – 400093
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Macleods Pharma LinkedIn page.
Documents to Carry:
- Updated CV / Resume
- Salary structure (CTC breakup)
- Aadhaar Card
Contact Numbers: 7208877803 / 8291054728
For more Regulatory Affairs jobs, USFDA jobs, Macleods Pharma jobs in Mumbai, and pharmaceutical opportunities across India, visit Pharma Recruiter.
Walk-in with your documents on 18 April 2026 and explore a promising career in Regulatory Affairs with Macleods Pharmaceuticals!
Why You Should Join Macleods
Macleods Pharmaceuticals provides a dynamic work environment with exposure to complex ANDA filings for the highly regulated US market. You will work on challenging regulatory projects involving solid orals, injectables, and MDIs while growing your expertise in one of the most demanding regulatory landscapes.
FAQs
What is the walk-in date and venue for Macleods Regulatory Affairs drive?
The walk-in is on 18 April 2026 from 09:00 AM onwards at Plot 60, MIDC Phase II, Andheri East, Mumbai – 400093.
Which experience level is required?
Candidates with 2 to 15 years of experience in US Regulatory Affairs are eligible.
What markets and products are covered?
The role focuses on the US Market with emphasis on solid oral, injectable, and MDI products.
What documents should I carry?
Bring your updated CV, salary structure (CTC breakup), and Aadhaar Card.
Is prior ANDA submission experience mandatory?
Yes, knowledge of preparing and submitting ANDA modules to US FDA is essential.
