Lupin
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.
Work Experience 2 to 3 years experience in regulatory submissions for Oral Solid Dosage (OSD) for the US market.
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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.
Work Experience 2 to 3 years experience in regulatory submissions for Oral Solid Dosage (OSD) for the US market.
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