Regulatory Affairs Jobs at Lupin| Chemistry Graduates Apply
Are you looking for regulatory affairs jobs with a leading pharmaceutical company? Lupin is hiring an Officer – Regulatory Affairs at its Airoli, Maharashtra location. This role offers an excellent opportunity for professionals seeking growth in Lupin Careers, especially those interested in regulated markets and lifecycle management of pharmaceutical products.
- Location: Airoli, MH, IN
- Company: Lupin
About Lupin
Lupin is a leading global pharmaceutical company known for its strong presence in regulated markets, including the USFDA-approved portfolio. With a focus on innovation, quality, and patient-centric solutions, Lupin Careers offers long-term growth opportunities across regulatory affairs, research, manufacturing, and quality functions.
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 to ensure 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 to ensure regulatory compliance 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
Competencies
- Customer Centricity
- Developing Talent
- Collaboration
- Strategic Agility
- Process Excellence
- Stakeholder Management
- Innovation & Creativity
- Result Orientation
Why Join Lupin?
Lupin is a globally recognized pharmaceutical company with a strong presence in regulated markets like the US. Working at Lupin offers hands-on exposure to USFDA regulatory processes, post-approval lifecycle management, and global compliance standards. With a collaborative culture and focus on innovation and quality, Lupin Careers provides excellent growth opportunities for professionals seeking long-term success in regulatory affairs jobs, including pharmacy graduates and MSc Chemistry Jobs aspirants.
