Regulatory Affairs Role At Lupin | Chemistry Graduates Apply Now
Are you looking for a dynamic opportunity to grow in regulatory affairs with a global pharmaceutical leader? The Officer – Regulatory Affairs role at Lupin offers hands-on experience in regulatory submissions, compliance, and lifecycle management for the US market. This position is ideal for professionals aiming to build a strong RA career within a world-class organization committed to innovation and quality healthcare.
About Lupin
Lupin is a global pharmaceutical company dedicated to improving the health and well-being of individuals around the world. With a focus on cutting-edge research, comprehensive regulatory affairs, and groundbreaking product development, Lupin is a leader in the pharmaceutical industry. Join us in our mission to deliver quality healthcare solutions. Candidates searching for regulatory affairs jobs, Lupin Jobs, and Chemistry Jobs at Lupin will find this role aligned with strong professional growth.
Job Location
Airoli, MH, IN
Job Description
- Lead regulatory submissions for Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance projects for the US market.
- Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA.
- Manage post-approval submissions and annual reports for USFDA-approved products, ensuring continuous regulatory compliance and lifecycle management.
- Drive labeling updates in line with changes to Reference Listed Drug (RLD) labeling approved by the USFDA.
- Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports), contributing to global pharmacovigilance and safety monitoring.
- Review and offer strategic input on documentation across product development, scale-up, and commercial manufacturing stages.
- Oversee document reviews for externally manufactured products, ensuring regulatory consistency and quality standards.
Work Experience
1 to 2 Years of experience in Regulatory Affairs for the Regulated Market
Education
- Graduation in Pharmacy
- Master’s in Science
Why You Should Join Lupin?
Joining Lupin means becoming part of a globally trusted pharmaceutical leader committed to innovation, quality, and patient well-being. At Lupin, you work alongside scientific and regulatory experts on impactful projects that improve global healthcare standards. With a strong culture of learning, career growth, and cutting-edge research, Lupin empowers you to develop your expertise while contributing to meaningful healthcare solutions. If you’re looking to advance your career in regulatory affairs with a company that values excellence, collaboration, and innovation, Lupin is the place to be.
