Lupin Limited, one of Indiaโs leading multinational pharmaceutical companies, is hiring an Officer โ Regulatory Affairs for its Airoli (Navi Mumbai) location. This opportunity is ideal for pharmacy or science postgraduates with 1โ2 years of Regulatory Affairs experience in regulated markets such as EU, UK, Canada, Australia, New Zealand, and the US.
If you are looking to build a long-term career in global regulatory submissions, eCTD publishing, and post-approval lifecycle management, this Lupin RA job offers strong exposure to international health authorities and complex generic products.
Key Responsibilities โ Regulatory Affairs Officer
As an Officer in the Regulatory Affairs department at Lupin, you will be responsible for:
- Preparing and submitting responses to deficiency letters from Health Authorities in Europe, Australia, New Zealand, and Canada
- Handling post-approval submissions for regulated markets (EU/UK, ANZ, Canada, US)
- Providing regulatory support during inspections by global regulatory authorities and customers
- Supporting product development, manufacturing, and testing from a regulatory perspective
- Evaluating and managing change proposals across the product lifecycle
- Compiling and reviewing CTD Module 2 and Module 3 documentation
- Working on new submissions, variations, and lifecycle management activities
- Ensuring compliance with ICH guidelines and country-specific regulatory requirements
- Performing hands-on eCTD compilation and publishing
- Supporting submissions for complex generics and multiple dosage forms
Educational Qualifications
- Masterโs degree required
- M.Pharm / MSc / Graduation in Pharmacy or Science
Work Experience Requirements
- 1โ2 years of experience in Regulatory Affairs
- Hands-on exposure to regulated markets such as:
- EU / UK
- Canada
- Australia & New Zealand
- US (preferred)
- Experience with:
- New dossiers and post-approval submissions
- Deficiency response management
- CTD Modules 2 & 3
- eCTD compilation tools
Key Skills & Competencies
- Strategic Agility
- Process Excellence
- Regulatory Compliance Expertise
- Collaboration & Stakeholder Management
- Result Orientation
- Customer Centricity
- Innovation & Creativity
- Ability to work in cross-functional teams
Why Join Lupin? (Benefits)
- Work with a globally recognized pharmaceutical company
- Exposure to multiple international regulatory markets
- Opportunity to work on complex generics
- Strong learning environment in global Regulatory Affairs
- Competitive salary aligned with industry standards
- Long-term career growth in regulatory leadership roles
Salary (Estimated)
๐ฐ โน4.5 โ โน7.0 LPA (CTC)
Salary may vary based on experience, skills, and internal policy.
Job Location
๐ Airoli, Navi Mumbai, Maharashtra, India
How to Apply
