Job Opportunity: Executive – Regulatory Affairs (US ANDA) at Lupin Ltd

Job Summary

Lupin Ltd, a global leader in the pharmaceutical industry, is currently seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team in Airoli, Mumbai. We are looking for an Executive – Regulatory Affairs (US ANDA) to manage and support complex submissions for the US market. This role is specifically designed for candidates with 2–3 years of experience in USFDA ANDA submissions, particularly within the Oral Solid Dosage (OSD) segment. This is an excellent opportunity to advance your career by working on global regulatory strategies, high-stakes lifecycle management, and rigorous USFDA compliance.

Job Description

As an Executive in our Regulatory Affairs department, you will play a critical role in the successful development and maintenance of our US market portfolio. You will be responsible for end-to-end ANDA regulatory submission processes, ensuring that all documentation meets the stringent requirements of the USFDA. You will work closely with cross-functional teams, including Quality Assurance, Quality Control, and Manufacturing, to navigate the regulatory landscape and maintain our commitment to product excellence and compliance.

Key Responsibilities

• Regulatory Submissions: Lead the preparation and submission of ANDA filings for Oral Solid Dosage (OSD) products destined for the US market.
• Deficiency Management: Proactively draft and submit comprehensive responses to USFDA deficiency letters to ensure timely approvals.
• Lifecycle Management: Manage post-approval submissions, annual reports, and various supplements, ensuring that all filings remain current and accurate.
• Compliance and Labeling: Oversee labeling updates in alignment with Reference Listed Drug (RLD) changes and support PADER reporting for pharmacovigilance compliance.
• Documentation Review: Review and validate regulatory documentation across various stages, including product development, scale-up, and commercialization.
• Cross-Functional Collaboration: Partner with internal departments to ensure regulatory requirements are integrated into manufacturing and quality processes, specifically for externally manufactured products.

Requirements

• Education: Bachelor’s degree in Pharmacy (B.Pharm). An M.Pharm degree is considered an added advantage.
• Experience: 2–3 years of hands-on experience specifically in US ANDA regulatory submissions.
• Technical Knowledge:
  • In-depth understanding of USFDA guidelines and eCTD submission protocols.
  • Strong proficiency in CMC (Chemistry, Manufacturing, and Controls) documentation (Module 3).
  • Expertise in lifecycle management, including variations and supplements.
• Competencies:
  • Strategic thinking with a strong mindset focused on regulatory compliance and process excellence.
  • Excellent communication skills with the ability to manage various internal and external stakeholders effectively.
  • Ability to prioritize tasks in a fast-paced, innovation-driven environment.

Benefits

• Compensation: Competitive salary package ranging from ₹4.5 LPA to ₹7.5 LPA, commensurate with industry standards and candidate experience.
• Professional Development: Direct exposure to global USFDA projects and regulated markets, providing a solid foundation for future roles as a Regulatory Affairs Manager or CMC Specialist.
• Work Environment: A collaborative, professional culture that encourages innovation and rewards process excellence.
• Career Growth: Clear opportunities for professional advancement within the global regulatory affairs domain.

How to Apply

If you meet the above requirements and are ready to take the next step in your regulatory career, please submit your application through the official Lupin Careers portal.

Apply for the Executive – Regulatory Affairs (US ANDA) Position Here

Lupin Ltd is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.