Executive
Apply now »Date: Aug 29, 2025
Location: Pune Biotech, RJ, IN
Company: Lupin
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