Officer – Regulatory Affairs Job at Lupin
Lupin is hiring an Officer – Regulatory Affairs for its Airoli location, offering an excellent opportunity for pharmacy and life science graduates to build a career in US regulatory submissions. This Regulatory Affairs Job role focuses on lifecycle management, post-approval submissions, and USFDA compliance across multiple dosage forms. Graduates seeking Pharmacy Jobs and want to start your career with Pharmacy Careers can apply now.
Job Details
- Job Title: Officer – Regulatory Affairs
- Location: Airoli, Maharashtra
About the Company
Lupin is a global pharmaceutical company with a strong presence in branded and generic formulations, APIs, and specialty products. Known for its regulatory excellence and strong USFDA portfolio, Lupin continues to expand its footprint in regulated markets through innovation, quality, and compliance-driven operations. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
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Graduation in Pharmacy
Key Responsibilities
- 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 USFDA deficiencies and queries is essential for this Regulatory Affairs Job role
- Manage post-approval submissions and annual reports for USFDA-approved products
- Drive labeling updates in alignment with Reference Listed Drug (RLD) changes approved by the USFDA
- Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports)
- Review regulatory documentation across product development, scale-up, and commercial manufacturing stages
- Oversee documentation review for externally manufactured products to ensure regulatory compliance
Skills Required for Regulatory Affairs Job
- Knowledge of USFDA regulatory submissions and lifecycle management
- Understanding of post-approval changes and labeling requirements
- Strong documentation review and regulatory strategy skills
- Ability to collaborate with cross-functional and external stakeholders
- Attention to detail and compliance-focused mindset
- Graduates seeking Pharmacy Jobs and want to start your career with Pharmacy Careers can apply now.
