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Officer - Regulatory Affairs Lupin Pharmaceuticals

1.0 - 5.0 years

0 Lacs

thane, all india

On-site

As a Regulatory Affairs Specialist, you will be responsible for leading regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market. Your role will involve ensuring timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. Additionally, you will manage post-approval submissions and annual reports for USFDA-approved products to ensure continuous regulatory compliance and lifecycle management. Key Responsibilities: - Drive labeling updates in alignment with changes to Reference Listed Drug (RLD) labeling approved by the USFDA. - Provide regulatory support ...

Posted 1 week ago

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