Regulatory Affairs Job at Lupin | Apply Now for the Officer Role
Lupin is inviting applications for the position of Officer – Regulatory Affairs based in Airoli, India. This opportunity is ideal for candidates seeking a Regulatory Affairs Job, with a focus on leading regulatory submissions for the US market, specifically for Inhalation, Nasal, and Oral Solid Dosage (OSD) projects. Candidates with 1–2 years of experience and a background in Pharmacy or Science will manage USFDA responses, lifecycle compliance, and strategic document reviews.
- Job Title: Officer – Regulatory Affairs
- Location: Airoli, MH, IN
About The Company
Lupin is a significant player in the global pharmaceutical industry, known for its extensive research and manufacturing capabilities. The company emphasizes Innovation & Creativity and Process Excellence in its pursuit of delivering high-quality healthcare solutions. In the field of Regulatory Affairs Job opportunities, Lupin focuses on maintaining a robust relationship with global health authorities, ensuring Strategic Agility and Result Orientation in its submissions and product lifecycle management.
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 within your Regulatory Affairs Job responsibilities.
- 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 in accordance with best practices.
Work Experience
- 1 to 2 Years of experience in Regulatory Affairs for the Regulated Market. Prior Regulatory Affairs Job experience preferred.
Education
- Graduation in Pharmacy. Educational background aligned with Regulatory Affairs Job requirements.
Competencies
- Customer Centricity
- Developing Talent
- Collaboration
- Strategic Agility
- Process Excellence
- Stakeholder Management
- Innovation & Creativity
- Result Orientation
