Regulatory Affairs Job at Lupin | Apply Now for the Officer Role
Lupin is seeking an Officer – Regulatory Affairs to join its team in Airoli, Maharashtra. This Regulatory Affairs Job requires 1 to 2 years of experience in Regulatory Affairs for Regulated Markets, specializing in US submissions for complex dosage forms, including Inhalation, Nasal, and Oral Solid Dosage (OSD) products. The Officer will be responsible for leading submissions, ensuring compliant responses to USFDA deficiencies, managing post-approval lifecycle activities (including Annual Reports), and driving labeling updates in alignment with Reference Listed Drug (RLD) changes.
- Job Title: Officer – Regulatory Affairs
- Location: Airoli, MH, IN
About the Company
Lupin is an Indian multinational pharmaceutical company and one of the world’s largest generics manufacturers, with a significant global presence. The company focuses on developing and commercializing a wide range of products, including complex generics like Inhalation and Nasal Dosage forms, primarily targeting highly regulated markets such as the US (USFDA). Pursuing a Regulatory Affairs Job within this department is crucial for securing and maintaining product approvals, ensuring strict compliance throughout the product lifecycle, from development through post-approval surveillance.
Lupin 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. A Regulatory Affairs Job demands such diligence.
- 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, a necessity for any successful Regulatory Affairs Job.
Work Experience
- 1 to 2 Years of experience in Regulatory Affairs for the Regulated Market
Education required for the Lupin Job
- Graduation in Pharmacy
Competencies
- Customer Centricity
- Developing Talent
- Collaboration
- Strategic Agility
- Process Excellence
- Stakeholder Management
- Innovation & Creativity
- Result Orientation
