Position: Regulatory Affairs Specialist
Location: Jeedimetla, Hyderabad
Qualification: M.Pharm, B.Pharm, MSc
Experience: 3 to 9 Years
Last Date to Apply: 10th August 2025
About Hetero Drugs
Hetero is a globally recognized pharmaceutical company and one of the world’s leading producers of Active Pharmaceutical Ingredients (APIs) and generic formulations. With a strong presence in 140+ countries and over 30 years of expertise, Hetero is committed to improving global healthcare by delivering high-quality, affordable medicines.
Job Description: Regulatory Affairs Specialist
As a Regulatory Affairs Specialist at Hetero, you will be responsible for handling regulatory submissions and compliance for emerging and ROW (Rest of the World) markets.
Key Responsibilities:
- Compilation and submission of ANDA (Abbreviated New Drug Application).
- Managing Life Cycle Management (LCM) of regulatory dossiers.
- Handling Post-Approval & Pre-Approval regulatory activities.
- Knowledge of Marketing Authorization Application (MAA).
- Experience in CMC (Chemistry, Manufacturing, and Controls) and Variations.
Desired Skills & Experience:
- 3-9 years of experience in Regulatory Affairs (Formulations).
- Strong understanding of global regulatory guidelines (USFDA, EMA, etc.).
- Ability to work in a fast-paced, deadline-driven environment.
How to Apply?
Interested candidates can email their updated CV to chandrasekhar.r@hetero.com with the subject line:
“Application For RA”
Last Date: 10th August 2025