Officer - Regulatory Affairs

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Date: Dec 8, 2025

Location: Airoli, MH, IN

Company: 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.
• 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.

Work Experience

1 to 2 Years of experience in regulatory Affairs for Regulated Market

Education

Graduation in Pharmacy
Masters in Science

Competencies

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

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