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 2 weeks ago

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Manager- Formulation Development- Inhalation Pune Extrius Consultants

8.0 - 13.0 years

9 - 12 Lacs

Pune, Solapur

Work from Office

Literature search and patent review of products. Responsible for formulation development of DPI & pMDIs formulations for US, EU, ROW, CSI and IRF markets. Responsible for planning and execution of development- Scale-up for pulmonary formulations. Required Candidate profile Must have experience into FD Inhalation 8-13years Exp Required Responsible for lab maintenance and upkeep of the laboratory and equipment’s.

Posted 6 months ago

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