Lupin looking for Regulatory Affairs Executive

Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees a peon-cum-packer and a part-time typist Lupin’s current global footprint spans 11 countries, across six continents. This journey has been made possible thanks to the vision and conviction of Dr. Desh Bandhu Gupta.

Post : Executive - RA

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 market.
• To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required.
• To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle

Candidate Profile
• Masters, Graduation in Pharmacy or Science
• Should have worked in 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 above markets.
• Worked on various dosage forms including complex generics.
• Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections.
• Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections.
• Hands on experiance for ECTD compilation.

Competencies
Strategic Agility
Process Excellence
Collaboration
Innovation & Creativity
Result Orientation
Stakeholder Management
Customer Centricity
Developing Talent

Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Airoli, MH
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September 2025