Hetero Labs Hiring Regulatory Affairs Executive (API) | Hyderabad | 2-5 Years Experience

Hetero Labs is seeking a highly motivated and experienced Regulatory Affairs Executive to join our API team in Hyderabad. The ideal candidate will be responsible for compiling Drug Master Files (DMFs) and Certificates of Suitability (CEPs), ensuring compliance with global market regulations and emerging market standards in accordance with ICH guidelines.

Join Hetero Labs’ Regulatory Affairs Team in Hyderabad

At Hetero Labs, we are committed to providing high-quality pharmaceutical products and fostering a culture of excellence. We offer a dynamic and challenging work environment where you can grow your career and contribute to the regulatory compliance of essential medicines. Join our team and be a part of a company that is dedicated to innovation and quality.

About Hetero Labs

Hetero Labs is a leading pharmaceutical company with a strong presence in the development, manufacturing, and marketing of branded and generic pharmaceuticals. We are committed to providing high-quality, affordable medicines to patients around the world.

Job Description

Regulatory Affairs Executive – API

The Regulatory Affairs Executive will be responsible for preparing and submitting regulatory dossiers for emerging and global markets, including Brazil, China, LATAM, US, EU, and ICH regions. You will stay updated with evolving regulatory requirements, handle regulatory filings, participate in deficiency meetings, review documents, and manage international regulatory projects. Strong knowledge of US, EU, and ICH regulatory guidelines is essential.

Qualifications & Experience

MSc (Organic Chemistry) / M.Pharm (Pharmaceuticals) / B.Pharm (Pharmaceuticals)
2-5 years of experience in Regulatory Affairs within the API industry
Experience in DMF and CEP compilation, amendments, and annual report filings
Detail-oriented with strong documentation and organizational abilities
Ability to handle multiple regulatory submissions while ensuring accuracy and compliance