Job Opportunity: Regulatory Affairs Professionals at Macleods Pharmaceuticals Ltd.

Summary

Macleods Pharmaceuticals Ltd. is hosting an exclusive walk-in drive for experienced Regulatory Affairs professionals to join their R&D center in Mumbai. We are seeking dedicated experts to contribute to our US market regulatory strategy, specifically focusing on Abbreviated New Drug Application (ANDA) submissions. This is a prime opportunity for professionals with 2 to 15 years of experience to advance their careers within a leading global pharmaceutical organization.

About the Role

As a key member of our Regulatory Affairs team at the Mumbai R&D center, you will be responsible for navigating the complexities of the US pharmaceutical market. Your primary focus will be on the preparation, compilation, and successful submission of regulatory dossiers to the US FDA. You will ensure that all departmental activities remain strictly compliant with evolving regulatory guidelines while managing product portfolios including solid orals, injectables, and MDI products.

Key Responsibilities

• Regulatory Submissions: Prepare and manage high-quality regulatory documents and ANDA modules for submission to the US FDA.
• Compliance Monitoring: Stay updated on current and changing FDA regulations to ensure all filings meet global quality standards.
• Lifecycle Management: Support regulatory documentation processes throughout the product lifecycle.
• Strategic Collaboration: Work closely with cross-functional R&D teams to streamline the submission process for diverse product categories, including injectables and solid dosage forms.

Eligibility Criteria

We are looking for candidates who demonstrate excellence in regulatory strategy and technical documentation.

• Experience: 2 to 15 years of relevant experience in Pharmaceutical Regulatory Affairs.
• Education: M.Pharm, B.Pharm, or M.Sc.
• Expertise: In-depth knowledge of US regulatory requirements, specifically regarding ANDA submissions, is mandatory. Candidates should be proficient in managing the end-to-end documentation processes required for regulatory approval.

Walk-in Interview Details

We invite eligible candidates to attend the interview in person. Please ensure you arrive promptly to facilitate a smooth screening process.

• Date: 18th April 2026
• Reporting Time: 09:00 AM onwards
• Venue: Macleods Pharmaceuticals Ltd., Plot No. 60, Street No. 14, MIDC Phase II, Andheri East, Mumbai – 400093.

Documentation Required

To participate in the selection process, please carry the following documents:

• Updated Curriculum Vitae (CV/Resume).
• Current Salary Structure (CTC Breakup).
• Aadhaar Card (or valid government-issued photo identification).

Why Join Macleods?

Macleods Pharmaceuticals Ltd. is a fast-growing, research-driven organization known for its commitment to quality and innovation. By joining our Regulatory Affairs team, you will be at the forefront of our US market operations, gaining exposure to complex regulatory challenges and working with a team of seasoned industry professionals. We offer a dynamic work environment where your expertise in ANDA submissions will be instrumental in bringing life-saving products to patients worldwide.

Important Instructions

• This is a direct walk-in event; no prior registration is required.
• Please ensure you have all mentioned documents ready to avoid delays.
• For any specific queries regarding the drive, you may contact the recruitment team at 7208877803 or 8291054728.

We look forward to meeting passionate professionals who are ready to elevate their regulatory careers with Macleods.