Executive
Lupin
2 - 5 years
Pune
Posted: 06/09/2025
Job Description
Job Description
| Drafting the regulatory submission files for domestic, emerging, and regulated markets. |
| Handling queries received from various health authorities. |
| Review of GMP documents as per the regulatory requirements. |
| Preparation of Post approval change (PAC) applications and other regulatory activities. |
| Coordination with the business partners for the marketing authorization applications in various geographies. |
| Understanding of regulatory requirements for biosimilar products is desirable. |
| Handling of online portals for various submissions in India, Emerging markets, and regulated markets. |
| Good oral and written communication are mandatory. |
Work Experience
2 to 4 years of relevant experience in regulated markets
Education
Competencies
About Company
Lupin Limited is a global pharmaceutical company based in Mumbai, India, specializing in generic and branded formulations, biotechnology products, and APIs. Founded in 1968, Lupin operates in over 100 countries and is known for its strong presence in therapeutic areas like cardiovascular, diabetes, respiratory, and anti-infectives. It is one of the top 10 generic pharma companies worldwide.
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