Hetero Hiring for Regulatory Affairs – Deputy General Manager Position

Hetero, a globally recognized pharmaceutical company, is inviting applications for the role of Deputy General Manager – Regulatory Affairs (API) at its HRF-I facility in Balanagar. This opportunity is ideal for individuals with a strong regulatory background, particularly in China, Brazil, and emerging markets, who are ready to lead cross-functional teams and engage with global regulatory authorities.

About Hetero

Hetero is one of India’s leading pharmaceutical companies with a strong global presence across more than 126 countries. Known for its robust API manufacturing capabilities and regulatory excellence, Hetero is committed to innovation, compliance, and delivering high-quality healthcare solutions.

Job Overview

Position: Deputy General Manager (DGM)

Department: Regulatory Affairs – API

Experience Required: 18 to 25 Years

Location: HRF-I, Balanagar, Hyderabad

Compensation: Negotiable based on experience

Application Email: vivek.s@hetero.com

Key Responsibilities

As Deputy General Manager of Regulatory Affairs, you will play a pivotal role in ensuring regulatory compliance and strategic regulatory planning across global markets. Your responsibilities will include:

• Leading regional regulatory teams with a strong focus on China, Brazil, and other emerging markets.
• Acting as a single point of contact for regulatory matters and major customer communications.
• Coordinating with cross-functional stakeholders to ensure technical accuracy and regulatory compliance throughout the product lifecycle.
• Managing and reviewing API CMC documentation, including IND, IMPD, and DMF submissions.
• Ensuring timely and effective responses to health authority queries during product registrations and lifecycle updates.
• Providing regulatory guidance and audit support during inspections by global regulatory bodies.
• Presenting key regulatory updates and strategies to senior stakeholders with confidence and clarity.

Candidate Profile

The ideal candidate will bring a strong combination of leadership, regulatory knowledge, and communication skills:

Educational Qualification: M.Pharm / B Pharm / MSc or equivalent in a relevant scientific discipline.

Experience: 18–25 years in Regulatory Affairs, with significant exposure to API documentation, CMC compliance, and international regulatory submissions.

How to Apply

If you meet the eligibility criteria and are excited to take on this leadership role, share your updated CV at:

vivek.s@hetero.com