Officer Job at Lupin | Pharmacy Graduates Apply Now
Lupin is hiring an Officer – Regulatory Affairs (RA) at its Airoli, Maharashtra location. This Officer Job is a prime opportunity for M.Pharm or M.Sc. graduates with 1–2 years of experience in regulated markets such as the EU, Australia, New Zealand, and Canada. The selected candidate will manage eCTD submissions, handle Response to Deficiencies (RTDs), and provide regulatory oversight for complex generics throughout their lifecycle.
- Position: Officer RA
- Location: Airoli, MH, IN
About The Company
Lupin Limited is a premier global pharmaceutical major and one of the world’s leading manufacturers of generic medicines. Headquartered in Mumbai, Lupin maintains a robust presence across 100+ countries, with a special focus on advanced markets like the US, Europe, and Australia. The Airoli facility in Maharashtra serves as a strategic hub for regulatory excellence, ensuring that Lupin’s wide portfolio—from basic generics to complex inhalation and nasal products—meets the most stringent international quality and safety standards.
Job Description
- Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand, and Canada market and Customers.
- Responsible for post approval submissions to Europe, Australia, New Zealand, and Canada markets.
- To provide Regulatory inputs during inspections by Regulatory authorities and customers as and when required.
- To provide Regulatory inputs during product development, manufacturing and testing, and to evaluate all types of change proposals duringthe product life cycle
Work Experience
- Should have worked in the Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US, etc. (minimum 1-2 years).
- Submission of new submissions, deficiency responses, and/or post-approval submissions for the above markets.
- Worked on various dosage forms, including complex generics.
- Compilation of Module 2 and 3 CTD sections for the above submissions. Review of documents for all these sections.
- Knowledge of ICH as well as country-specific guidance for documents to be submitted in all the above sections.
- Hands-on experience for ECTD compilation.
Education
- Master’s Graduation in Pharmacy or Science is required for the Lupin Job
