Regulatory Affairs Associate (US Market)

Why This Role Matters
This role is critical in ensuring that pharmaceutical products meet stringent regulatory requirements for the US market. By managing ANDA submissions, post-approval changes, and compliance activities, you directly support timely product approvals, lifecycle management, and patient access to safe and effective medicines.

Job Description
Lupin is hiring an Executive – Regulatory Affairs (US ANDA) for its Airoli (Mumbai) location. This role focuses on handling regulatory submissions for Oral Solid Dosage (OSD) products in the US market, ensuring compliance with USFDA requirements, and supporting lifecycle management activities.

Key Features of the Role:
• Exposure to US regulatory framework (USFDA)
• Hands-on experience with ANDA submissions and lifecycle management
• Involvement in labeling updates and regulatory strategy
• Opportunity to work on global pharmaceutical products
• Cross-functional collaboration with R&D, manufacturing, and QA teams

Responsibilities
• Lead regulatory submissions for Oral Solid Dosage (OSD) products for the US market
• Prepare and submit ANDA dossiers in compliance with regulatory guidelines
• Respond to product deficiencies and queries raised by USFDA
• Manage post-approval submissions and annual reports for approved products
• Drive labeling updates in alignment with Reference Listed Drug (RLD) changes
• Provide regulatory support for PADER (Periodic Adverse Drug Experience Reports)
• Review documentation across product development, scale-up, and commercialization stages
• Ensure regulatory compliance for externally manufactured products
• Collaborate with cross-functional teams for submission readiness and compliance

Required Qualifications
• Strong understanding of US regulatory requirements (ANDA, USFDA guidelines)
• Knowledge of lifecycle management and post-approval changes
• Familiarity with labeling requirements and pharmacovigilance reporting

Educational Requirements:
• Bachelor’s Degree in Pharmacy (B.Pharm)

Experience and Skills:
• 2–3 years of experience in regulatory submissions for OSD (US market)
• Hands-on experience in ANDA filing and deficiency response handling
• Strong documentation and technical writing skills
• Good understanding of pharmaceutical development lifecycle
• Effective communication and stakeholder management skills
• Ability to work in cross-functional teams
• Problem-solving mindset with attention to detail

Salary Insights
• Estimated salary range: ₹4 LPA – ₹8 LPA (based on experience and company standards)

Company Overview
Lupin is one of India’s leading pharmaceutical companies with a strong global presence. Known for its expertise in generics and complex formulations, Lupin operates in multiple international markets including the US, offering employees exposure to global regulatory environments and advanced pharmaceutical development practices.

FAQs
• What is ANDA in this role?
ANDA (Abbreviated New Drug Application) is required for approval of generic drugs in the US market.

• Is USFDA experience mandatory?
Yes, experience with US regulatory submissions (especially ANDA) is essential.

• What is RLD?
Reference Listed Drug (RLD) is the innovator drug used as a reference for generic drug approval.

• What is the career growth path?
Executive → Senior Executive → Assistant Manager → Manager (Regulatory Affairs)

Application Tips
• Highlight your experience with ANDA submissions and USFDA interactions
• Mention specific involvement in deficiency responses or labeling updates
• Showcase your understanding of OSD formulations and lifecycle management
• Emphasize documentation and regulatory writing skills
• Prepare examples of cross-functional collaboration and compliance handling