Lupin looking for Regulatory Affairs Officer

Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees a peon-cum-packer and a part-time typist Lupin’s current global footprint spans 11 countries, across six continents. This journey has been made possible thanks to the vision and conviction of Dr. Desh Bandhu Gupta.

Post : Regulatory Affairs Officer

Job Description
• Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market.
• Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA.
• Manage post-approval submissions and annual reports for USFDA-approved products, ensuring continuous regulatory compliance and lifecycle management.
• Drive labeling updates in line with changes to Reference Listed Drug (RLD) labeling approved by the USFDA.
• Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports), contributing to global pharmacovigilance and safety monitoring.
• Review and offer strategic input on documentation across product development, scale-up, and commercial manufacturing stages.
• Oversee document reviews for externally manufactured products, ensuring regulatory consistency and quality standards.

Candidate Profile
Graduation in Pharmacy
Masters in Science
1 to 2 Years of experience in regulatory Affairs for Regulated Market

Competencies
Customer Centricity
Developing Talent
Collaboration
Strategic Agility
Process Excellence
Stakeholder Management
Innovation & Creativity
Result Orientation

Additional Information
Experience : 1 to 2 Years
Qualification : B.Pharm, MSc
Location : Airoli, MH
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th December 2025