Lupin Limited, one of India’s leading global pharmaceutical companies, is hiring Officer – Regulatory Affairs at its Airoli, Maharashtra facility. This opportunity is ideal for B.Pharm or MSc graduates with 1–2 years of experience in Regulatory Affairs for regulated markets, particularly the USFDA market.
The role focuses on regulatory submissions, lifecycle management, post-approval documentation, and compliance for inhalation, nasal, and oral solid dosage (OSD) products. Candidates with strong knowledge of US regulatory guidelines, submission documentation, and labeling updates will be highly suited for this position.
This is an excellent opportunity for professionals aiming to build a career in Regulatory Affairs, USFDA submissions, ANDA lifecycle management, and pharmaceutical regulatory compliance.
Job Details
Position: Officer – Regulatory Affairs
Company: Lupin Limited
Location: Airoli, Maharashtra, India
Experience: 1–2 Years
Qualification: B.Pharm / M.Sc
Industry: Pharmaceutical / Regulatory Affairs
Key Responsibilities
The selected candidate will work on regulatory operations and submissions related to regulated markets.
Major responsibilities include:
- Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance products targeting the US market
- Ensure timely responses to product deficiencies raised by regulatory authorities including USFDA
- Manage post-approval submissions and annual reports for USFDA approved products
- Handle regulatory lifecycle management activities for marketed pharmaceutical products
- Drive labeling updates in accordance with Reference Listed Drug (RLD) changes approved by USFDA
- Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports) and pharmacovigilance reporting
- Review and provide regulatory inputs during product development, scale-up, and commercial manufacturing stages
- Review regulatory documentation for externally manufactured products ensuring compliance and quality standards
Eligibility Criteria
Candidates applying for the Lupin Regulatory Affairs job must meet the following requirements:
Educational Qualification
- Bachelor’s Degree in Pharmacy (B.Pharm)
OR - Master’s Degree in Science (M.Sc)
Experience
- 1–2 years of experience in Regulatory Affairs
- Experience in regulated markets (USFDA preferred)
Required Competencies
Lupin is looking for professionals with the following skills:
- Regulatory documentation expertise
- USFDA regulatory understanding
- Process excellence and compliance awareness
- Stakeholder management and collaboration
- Strategic thinking and innovation mindset
- Result orientation and customer centricity
Why Join Lupin?
Lupin is a globally recognized pharmaceutical company known for innovation, quality, and regulatory excellence.
Employees benefit from:
- Opportunities to work on USFDA regulated market submissions
- Exposure to global pharmaceutical regulatory frameworks
- Career growth in Regulatory Affairs and pharmaceutical compliance
- Collaborative work environment with experienced regulatory professionals
- Experience with complex dosage forms including inhalation and nasal products
How to Apply
