Hetero Hiring for Regulatory Affairs Formulation (US, EU, ROW) Role

Hetero, a leading pharmaceutical company known for its innovative drug formulations and high-quality products, is hiring Regulatory Affairs professionals specializing in Formulations for US, EU, and ROW markets. This is an excellent opportunity to work with a reputed organization that emphasizes research, innovation, and global regulatory compliance.

Job Details

• Position: Regulatory Affairs – Formulation (US, EU, ROW)
• Location: Jeedimetla, Hyderabad, Telangana
• Experience Required: 3 to 9 years
• Qualification: M Pharma, B Pharma, M Sc
• Work Type: Full-time
• Mode of Hiring: Walk-in Interview

Roles & Responsibilities

• Review, compile, and submit ANDAs (Abbreviated New Drug Applications) to regulatory authorities.
• Ensure life cycle management of regulatory submissions, handling post-approval and pre-approval requirements.
• Prepare and submit MAA (Marketing Authorization Applications) for EU and ROW markets.
• Manage regulatory compliance, coordinate with internal teams, and ensure timely approvals.
• Stay updated with changing regulatory guidelines in US, EU, and ROW regions.

Key Skills Required

• Strong knowledge of ANDA submission processes and dossier compilation.
• Experience in life cycle management of regulatory affairs.
• Understanding of post-approval variations and regulatory compliance.
• Proficiency in preparing and handling Marketing Authorization Applications (MAA).
• Familiarity with international regulatory requirements for the US, EU, and ROW markets.

Walk-in Interview Details

• Date: 16th February 2025 (Sunday)
• Time: 09:00 AM – 03:00 PM
• Venue: Hetero Labs Limited, Unit VII, Jeedimetla, Qutubullapur (M), Medchal District, Hyderabad, Telangana.
• Contact Email: Chandrasekhar.r@hetero.com