Lupin Regulatory Affairs Executive Jobs

Lupin Hiring Executive – Regulatory Affairs | High-Impact Pharma Regulatory Jobs in Pune Biotech

Lupin is hiring for Executive – Regulatory Affairs roles in its Biotech division at Pune. This is a full-time opportunity for professionals with 3–5 years of experience in regulatory submissions, dossier preparation, and global compliance. The role sits within the Regulatory Affairs department and focuses on handling submissions across domestic, emerging, and regulated markets. While the exact number of vacancies is not disclosed, multiple openings are expected in the regulatory team supporting global product registrations and lifecycle management.

This position is ideal for candidates aiming to build long-term careers in regulatory affairs, biosimilars, and global pharmaceutical compliance.

Company Overview

Lupin is a globally recognized pharmaceutical company with a strong footprint across generics, complex formulations, and biotechnology products. With operations in over 100 countries, the company is known for its regulatory strength, innovation-driven manufacturing, and high-quality healthcare solutions.

The Pune Biotech facility plays a critical role in biologics and biosimilars development, supporting global submissions and compliance with USFDA, EMA, and other international regulatory agencies. Working at Lupin offers exposure to global regulatory frameworks, advanced submission strategies, and cross-functional collaboration with R&D, Quality, and manufacturing teams.

Job Role & Responsibilities

As an Executive – Regulatory Affairs, you will manage regulatory documentation, submissions, and interactions with health authorities across multiple markets.

• Draft and compile regulatory submission dossiers for domestic, emerging, and regulated markets
• Handle queries and deficiency letters from global health authorities
• Review GMP-related documents to ensure compliance with regulatory standards
• Prepare post-approval change (PAC) applications and lifecycle management submissions
• Coordinate with global business partners for marketing authorization applications (MAA)
• Manage submissions through online regulatory portals across different geographies
• Ensure accurate documentation, archiving, and traceability of regulatory files
• Support regulatory strategies for product approvals and compliance
• Collaborate with cross-functional teams including QA, R&D, and manufacturing

This role directly contributes to product approvals, regulatory compliance, and timely market access for pharmaceutical and biotech products.

Eligibility / Qualifications

Candidates must meet the following criteria:

• Master’s degree in Biotechnology or Pharmacy
• Post-graduation in Biopharmaceutics or Pharmaceutical Technology preferred
• 3–5 years of experience in regulatory affairs or related functions

Relevant courses include: M.Pharmacy, MSc Biotechnology, MSc Biopharmaceutics, Pharmaceutical Technology, Regulatory Affairs, Pharmaceutics

Key skills required:

• Strong knowledge of global regulatory submission processes
• Experience with dossier preparation and lifecycle management
• Understanding of GMP documentation and compliance standards
• Familiarity with biosimilar regulatory requirements (preferred)
• Experience with regulatory submission portals and systems
• Strong communication and stakeholder coordination skills
• Attention to detail and regulatory risk assessment ability

Location & Salary

• Location: Pune Biotech, Maharashtra
• Work Mode: Onsite
• Salary: Approximately ₹8 LPA – ₹16 LPA (based on regulatory affairs roles in India with 3–5 years experience)

Application Process

Interested candidates can apply through the official Lupin careers portal:

Apply Here: https://careers.lupin.com/job/Pune-Biotech-Executive-Regulatory-Affairs-MH/1385557700/

Ensure your resume highlights your regulatory submission experience, dossier preparation skills, and exposure to global markets to improve your chances of selection.

Frequently Asked Questions (FAQs)

1. What is the main responsibility of this role?
The role focuses on regulatory submissions, dossier preparation, and handling health authority queries.

2. What qualifications are required?
Candidates need a Master’s degree in Pharmacy or Biotechnology.

3. Is experience mandatory?
Yes, 3–5 years of regulatory affairs experience is required.

4. What markets will I work on?
Domestic, emerging, and regulated markets including global submissions.

5. Is biosimilar experience required?
It is preferred but not mandatory.

Summary Table

Company	Lupin
Vacancies	Executive – Regulatory Affairs
Required Education	M.Pharmacy, MSc Biotechnology, Pharmaceutical Technology
Experience	3–5 Years