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Officer - Regulatory Affairs
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2025-12-10
Listing for:
Lupin
Full Time
position Listed on 2025-12-10
Job specializations:
-
Healthcare
Healthcare Compliance, Healthcare Management
Job Description & How to Apply Below
Officer - Regulatory Affairs
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 bythe 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.
1 to 2 Years of experience in regulatory Affairs for Regulated Market
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