Regulatory Affairs Job at Lupin | Apply for the Officer Role
Lupin is hiring an Officer – Regulatory Affairs in Airoli, India, to spearhead US market submissions for Inhalation, Nasal, and Oral Solid Dosage (OSD) projects. The Regulatory Affairs Job involves managing USFDA responses, post-approval compliance, labeling updates, and providing strategic input from development to commercial stages. Ideal candidates in this Officer Job hold a B.Pharm or M.Sc. with 1–2 years of experience in regulated market regulatory affairs.
- Job Title: Officer – Regulatory Affairs
- Location: Airoli, MH, IN
About Lupin
Lupin Limited is a global pharmaceutical powerhouse and one of the largest generic drug manufacturers in the world, founded in 1968 with an initial mission to eradicate life-threatening diseases like Tuberculosis. Today, it stands as a dominant force in the US and Indian markets, particularly renowned for its technical “moat” in high-entry-barrier segments such as Respiratory (Inhalers and Nasal Sprays), Cardiovascular, and Diabetology. By investing roughly 7–9% of its annual revenue back into R&D, Lupin has transitioned from a traditional generics player into an innovation-led organization focused on complex generics and biosimilars.
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
Competencies
- Customer Centricity
- Developing Talent
- Collaboration
- Strategic Agility
- Process Excellence
- Stakeholder Management
- Innovation & Creativity
- Result Orientation
