Officer - Regulatory Affairs

3 days ago


Navi Mumbai, Maharashtra, India Lupin Full time ₹ 25,00,000 - ₹ 45,00,000 per year
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 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

1 to 2 Years of experience in regulatory Affairs for Regulated Market

Education
Graduation in Pharmacy Masters in Science Competencies
Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation

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