Pharmacy Job at Lupin | Apply Now for the Executive Position
Lupin is hiring an Executive – Regulatory Affairs (US ANDA) at its Airoli, Maharashtra facility. This Pharmacy Job is ideal for Pharmacy graduates with 2–3 years of experience in the US regulatory environment, focusing on Oral Solid Dosage (OSD) forms. The selected candidate will lead high-stakes USFDA submissions, manage post-approval compliance, and drive labeling updates for one of the industry’s most robust generic portfolios.
- Position: Executive – RA
- Location: Airoli, MH, IN
About The Company
Lupin Limited is a premier global pharmaceutical major and one of the world’s leading manufacturers of generic medicines. Headquartered in Mumbai, Lupin maintains a dominant presence in the US market, where it is recognized for its extensive portfolio of ANDA (Abbreviated New Drug Application) approvals. The Airoli facility in Maharashtra is a center of regulatory excellence, focused on driving high-impact submissions for Oral Solid Dosage (OSD) forms and ensuring unwavering compliance with USFDA standards throughout the product lifecycle.
Job Description
- Lead regulatory submissions for Oral Solid Dosage (OSD) 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.
Education
- A graduation in Pharmacy is required for the Lupin Job
Work Experience
- 2 to 3 years of experience in regulatory submissions for Oral Solid Dosage (OSD) for the US market.
Competencies
- Strategic Agility
- Process Excellence
- Collaboration
- Innovation & Creativity
- Result Orientation
- Stakeholder Management
- Customer Centricity
- Developing Talent
