Officer – Regulatory Affairs at Lupin

Lupin Limited, a leading global pharmaceutical company, invites applications for the position of Officer – Regulatory Affairs in Airoli, Maharashtra. This role is ideal for pharmacy graduates or MSc professionals with 1–2 years of experience in regulatory affairs for regulated markets, particularly USFDA submissions. If you are passionate about regulatory compliance, lifecycle management, and strategic project leadership, this is your opportunity to join a dynamic team at Lupin.

Key Responsibilities

• Lead regulatory submissions for US market projects, including Inhalation, Nasal, Oral Solid Dosage (OSD), Contract Manufacturing, and Strategic Alliance products.
• Ensure timely responses to product deficiencies raised by US regulatory authorities (USFDA).
• Manage post-approval submissions and annual reports for USFDA-approved products, ensuring ongoing compliance.
• Drive labeling updates aligned with Reference Listed Drug (RLD) approvals by the USFDA.
• Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports), supporting global pharmacovigilance initiatives.
• Review and provide strategic input on documentation during product development, scale-up, and commercial manufacturing.
• Oversee regulatory documentation for externally manufactured products, ensuring consistency and quality standards.

Qualifications & Experience

• Graduation in Pharmacy or a Master’s in Science (MSc).
• 1–2 years of experience in regulatory affairs for US regulated markets.
• Strong understanding of USFDA regulations, product lifecycle management, and regulatory submission processes.
• Competencies in stakeholder management, strategic agility, collaboration, process excellence, and innovation.

Benefits

• Competitive salary range INR 6–10 LPA (based on experience).
• Exposure to USFDA-regulated products and global regulatory practices.
• Career growth with learning opportunities in pharmaceutical regulatory affairs.
• Collaborative work culture fostering innovation and result orientation.

How to Apply

Application Link