Lupin Limited, a globally recognized pharmaceutical company, is inviting applications for Executive – Regulatory Affairs (US ANDA) and Manager – Regulatory Affairs (EANC regions) at its Airoli, Mumbai location. These opportunities are ideal for regulatory professionals with hands-on experience in USFDA submissions, ANDA lifecycle management, and global regulatory dossiers across the US, Europe, Australia, New Zealand, and Canada.
If you are looking to accelerate your career in Regulatory Affairs jobs in India, this is an excellent opportunity to work with a leading pharma major known for innovation, compliance excellence, and global reach.
Position 1: Executive – Regulatory Affairs (US ANDA)
Key Responsibilities
- Lead regulatory submissions for Oral Solid Dosage (OSD) products for the US market
- Prepare and submit US ANDA dossiers in compliance with USFDA regulations
- Respond to USFDA deficiencies and queries within defined timelines
- Manage post-approval submissions, amendments, and annual reports
- Drive labeling updates in alignment with Reference Listed Drug (RLD) changes
- Provide regulatory support for PADER submissions and pharmacovigilance activities
- Review regulatory documentation across product development, scale-up, and commercial manufacturing
- Oversee regulatory reviews for externally manufactured products
Work Experience
- 2–3 years of experience in US regulatory submissions (OSD)
Educational Qualification
- Bachelor’s Degree in Pharmacy (B.Pharm)
Position 2: Manager – Regulatory Affairs (EANC)
Key Responsibilities
- Review and guide dossier preparation for Europe, Australia, New Zealand, and Canada (EANC) markets
- Lead responses to regulatory authority and customer queries in EANC regions
- Liaise with R&D, manufacturing plants, clinical teams, and regional business teams
- Support lifecycle management and variation approvals for EANC-registered products
- Maintain regulatory databases and documentation systems
- Stay updated with global regulatory guidelines and eCTD requirements
- Prepare, review, and submit GMP applications
Educational Qualification
- B.Pharm / M.Pharm (preferred)
Experience
- Relevant experience in global regulatory affairs and dossier management
Core Competencies (Both Roles)
- Strategic Agility
- Process Excellence
- Result Orientation
- Collaboration & Stakeholder Management
- Customer Centricity
- Innovation & Creativity
- Talent Development & Leadership
Salary & Benefits (Indicative)
- Executive – RA (US ANDA): ₹6,00,000 – ₹9,00,000 per annum
- Manager – RA (EANC): ₹14,00,000 – ₹22,00,000 per annum
Additional Benefits:
- Industry-leading learning & development programs
- Exposure to global regulatory markets
- Career growth within a top-tier pharmaceutical organization
- Competitive compensation and performance incentives
How to Apply
Application Link Executive – Regulatory Affairs (US ANDA)
Application Link Manager – Regulatory Affairs (EANC)
