Regulatory Affairs Openings at Hetero Pharma

Are you an experienced professional in Regulatory Affairs (RA) looking to grow your career with one of India’s leading pharmaceutical companies? Hetero, a global leader in formulations and APIs, is hiring Regulatory Affairs Specialists at its Jeedimetla, Hyderabad facility.

This opportunity is ideal for candidates with expertise in ANDA, CMC, MAA submissions, lifecycle management, and post-approval/pre-approval processes.

Key Responsibilities

As a Regulatory Affairs Specialist at Hetero, you will:

• Review, compile, and submit Abbreviated New Drug Applications (ANDA).
• Manage Life Cycle Management (LCM) of pharmaceutical products.
• Handle both Pre-approval and Post-approval submissions.
• Work on Marketing Authorization Applications (MAA) for global markets.
• Support CMC documentation and variations for regulatory compliance.

Qualifications & Experience

• Education: M.Pharm / B.Pharm / M.Sc in Pharmaceutical Sciences or related field.
• Experience: 3 to 9 years in Regulatory Affairs (Formulations – Emerging, ROW markets).
• Strong knowledge of CMC, regulatory documentation, and variations.
• Hands-on experience with global regulatory submissions.

Why Join Hetero?

• Work with one of India’s top pharmaceutical companies with a global presence.
• Exposure to international regulatory markets.
• Opportunity to advance in Regulatory Affairs career path.
• Competitive salary and benefits package.

Application Process

Interested candidates should email their CVs to:

📧 chandrasekhar.r@hetero.com
Subject Line: Application For RA