About the Company
Lupin Limited is a leading multinational pharmaceutical company headquartered in Mumbai, India. Ranked among the top generic pharmaceutical companies globally, Lupin specializes in high-quality generics, branded formulations, and active pharmaceutical ingredients.
The company maintains a strong commitment to innovation, research & development, and stringent regulatory compliance. With multiple USFDA-approved facilities and presence in over 100 countries, Lupin offers a dynamic platform for pharmaceutical careers in India.
Employees thrive in an environment focused on excellence, patient-centric solutions, and sustainable growth.
Job Details
- Company Name: Lupin
- Experience: Fresher to 1 year (Dossier compilation experience or awareness of quality guidelines preferred)
- Qualification: Graduation in Pharmacy (B.Pharm) or Masters in Chemistry (M.Sc)
- Location: Santacruz, Mumbai, Maharashtra, India
- Work Type: On-site
Job Description
Lupin is seeking motivated professionals for its Regulatory Affairs team at the Santacruz location. This Officer – RA position focuses on supporting critical regulatory submissions for global markets.
Ideal for freshers eager to build expertise in pharmaceutical regulatory processes and compliance.
Officer – Regulatory Affairs
- Department: Regulatory Affairs
- Experience: Fresher to 1 year
- Education/Qualification: Graduation in Pharmacy or Masters in Chemistry
- Role: Support regulatory submissions including Annual Reports, supplements, new product launches, labeling amendments, and responses to regulatory queries (DRL/IR, Complete Response Amendments)
Skills/Qualifications
- Graduation in Pharmacy or Masters in Chemistry
- 0–1 year experience with dossier compilation preferred
- Awareness of quality guidelines and regulatory standards
- Strong attention to detail and documentation skills
- Excellent written and verbal communication
- Ability to manage multiple tasks effectively
- Proficiency in MS Office and regulatory databases
Key Responsibilities
- Prepare annual reports and supplements
- Support new product launch submissions
- Handle labeling amendment filings
- Draft responses to Discipline Review Letters
- Assist with Information Request responses
- Support Complete Response Amendment preparation
- Ensure timely and accurate regulatory documentation
- Coordinate with cross-functional teams
Benefits/Perks
- Competitive salary package
- Comprehensive health insurance
- Professional development programs
- Exposure to global regulatory processes
- Collaborative and innovative work culture
- Learning opportunities in USFDA submissions
- Career progression in regulatory affairs
- Work-life balance initiatives
How to Apply
Interested candidates should apply through the official Lupin careers portal. Visit www.lupin.com/careers to search for current openings and submit your updated resume. Mention “Officer – Regulatory Affairs” in your application.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Lupin Career page.
Freshers are encouraged to apply highlighting relevant academic projects or internships. Take the next step in your pharma regulatory career—apply today! For more regulatory affairs jobs and pharma opportunities, explore .
Why You Should Join
Lupin provides an exceptional platform for professionals entering regulatory affairs. With a reputation for quality and innovation, employees gain hands-on experience in international submissions.
The company fosters talent development through structured training and mentorship. Join a patient-centric organization committed to affordable healthcare worldwide. Build a rewarding, long-term career in one of India’s most respected pharmaceutical companies.