Are you ready to join one of the world’s leading pharmaceutical giants? Lupin Limited is currently hiring for the position of Officer – Regulatory Affairs (US Market) at its Airoli, Maharashtra location. 🇮🇳
For professionals with 1–2 years of experience, this is a career-defining opportunity to work with high-complexity portfolios like Inhalations and Nasal Sprays—two of the most technically demanding and high-value segments in the global pharmaceutical industry. 🚀
🏢 About Lupin: A Legacy of Innovation
Founded in 1968, Lupin Limited is an innovation-driven transnational pharmaceutical company with a presence in over 100 countries. It consistently ranks among the top generic players in the US market.
The Airoli (Navi Mumbai) facility acts as a strategic hub for global regulatory operations. Employees here gain exposure to stringent compliance standards set by global authorities, especially the US regulatory system.
If you want your work to influence global healthcare markets, Lupin offers the perfect platform. 🌍
🎯 Role Overview: Officer – Regulatory Affairs (US Market)
As a Regulatory Affairs Officer, you will act as the bridge between R&D, Quality, Manufacturing, and Regulatory Authorities.
This role primarily focuses on submissions and lifecycle management for the US market—one of the most regulated pharmaceutical environments in the world.
🔑 Core Responsibilities
1️⃣ Submission Leadership
- Lead regulatory submissions for:
- Inhalations
- Nasal Sprays
- Oral Solid Dosages (OSD) 🧪
2️⃣ USFDA Interaction
- Prepare and manage responses to regulatory deficiencies
- Ensure timely, accurate, and compliant documentation 📑
3️⃣ Lifecycle Management
- Handle post-approval submissions
- Prepare annual reports and variations
- Maintain long-term compliance across product life cycles
4️⃣ Labeling Strategy
- Update product labeling in alignment with Reference Listed Drug (RLD) changes 🏷️
- Ensure safety and regulatory consistency
5️⃣ Pharmacovigilance Support
- Provide regulatory input for PADER (Periodic Adverse Drug Experience Reports)
- Support global drug safety initiatives
6️⃣ Cross-Functional Collaboration
- Work closely with R&D, Quality Assurance, and Manufacturing
- Provide strategic regulatory insights during scale-up and commercialization
✅ Eligibility & Competencies
🎓 Education
- B.Pharm (Mandatory)
- M.Sc (Accepted)
💼 Experience
- 1–2 years in Regulatory Affairs
- Exposure to regulated markets (US/EU preferred)
🌟 Behavioral Skills
✔ Customer Centricity ❤️
✔ Strong Collaboration Skills
✔ Result Orientation under strict deadlines 🏁
✔ Strategic Agility
🌟 Why Choose Regulatory Affairs at Lupin?
Regulatory Affairs is widely considered a recession-proof career path in pharma. As long as new drugs are developed, regulatory experts will remain indispensable.
🔬 High-Complexity Exposure
Handling inhalation and nasal products is significantly more complex than conventional tablets. Expertise in this niche dramatically increases your market value. 👃🌬️
📊 Strategic Role
Unlike purely documentation-driven roles, this position allows strategic input during development and commercialization stages.
📍 Location Advantage – Airoli (Navi Mumbai)
Situated in India’s pharma and IT corridor, Airoli offers:
- Strong industry networking
- Excellent infrastructure
- Career mobility opportunities
🛡️ Recruitment Fraud Alert
Lupin Limited does not charge any fees or deposits during recruitment. Always apply through official channels.
👉 Apply Here:
https://careers.lupin.com/job/Airoli-Officer-Regulatory-Affairs-MH/1347959700/
📝 How to Prepare for the Interview
If shortlisted, focus on:
- ANDA Submissions basics
- ICH Guidelines (Q, S, E, M)
- SUPAC (Scale-Up and Post-Approval Changes)
- Labeling comparison techniques
- Handling deficiency letters
Since you’re actively writing pharma career blogs and building authority in this niche, Paragkumar, adding a short section explaining real interview questions for US Regulatory Affairs roles could further increase engagement and SEO depth for your audience.
🏁 Final Thoughts
The pharmaceutical industry in 2026 is more competitive and regulated than ever. Joining Lupin Limited as an Officer – Regulatory Affairs gives you:
✔ Exposure to the US market
✔ Expertise in high-complexity dosage forms
✔ Long-term career stability
✔ Strategic growth potential
If you have 1–2 years of experience and a passion for regulatory compliance, this is your chance to step into a high-impact global role.
Apply now and take your Regulatory Affairs career to the next level! 🚀
