More jobs:
Executive - RA; US ANDA
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-02-01
Listing for:
Lupin
Full Time
position Listed on 2026-02-01
Job specializations:
-
Healthcare
Healthcare Management, Healthcare Compliance
Job Description & How to Apply Below
Location: Indiana
Executive - RA (US ANDA)
Date: Jan 20, 2026
Company: Lupin
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.
2 to 3 years experience in regulatory submissions for Oral Solid Dosage (OSD) for the US market.
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