Regulatory Affairs Job at Lupin | Apply Now
Lupin is seeking a highly motivated Officer – Regulatory Affairs to join its team in Airoli, Maharashtra. This entry-level Regulatory affairs job is crucial for managing regulatory submissions across diverse dosage forms (Inhalation, Nasal, OSD), specifically for the US market. If an applicant holds a degree in Pharmacy or a Master’s in Science and possesses 1 to 2 years of relevant experience, this is a prime opportunity to accelerate their Lupin career in a regulated pharmaceutical environment.
- Designation: Officer – Regulatory Affairs
- Location: Airoli, MH, IN
About The Company
Lupin is a leading global pharmaceutical company known for its focus on complex generics and innovative products. The Regulatory Affairs team is integral to ensuring products meet the stringent requirements of international agencies like the USFDA, allowing the company to successfully launch and maintain its portfolio in regulated markets.
Key Responsibilities
This Regulatory affairs job is focused on the tactical execution of submissions and maintaining the regulatory status of commercial products in the US.
- US Submissions & Responses: 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 (USFDA).
- Lifecycle Management: Manage post-approval submissions and annual reports for USFDA-approved products.
- Labeling & PV Support: 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).
- Documentation Review: Review and offer strategic input on documentation across product development, scale-up, and commercial manufacturing stages. Oversee document reviews for externally manufactured products.
Job Requirements:
Education & Experience
- Education: Masters in Science.
- Experience: 1 to 2 Years of experience in Regulatory Affairs for a Regulated Market.
Core Competencies
- Process Excellence
- Strategic Agility
- Stakeholder Management
- Result Orientation
- Innovation & Creativity
- Collaboration, Customer Centricity, and Developing Talent.
If an applicant is a recent graduate with 1–2 years of experience and a passion for US regulatory compliance, this Regulatory affairs job in Airoli is an ideal step up. They should apply now to establish a strong foundation in submissions and product lifecycle management within their Lupin career.
