Hetero Job Openings for Regulatory Affairs – API (US, EUROPE, ROW)
Hetero Labs is actively seeking skilled professionals to join its Regulatory Affairs team, specifically within the API (Active Pharmaceutical Ingredients) division. With positions available for various levels of experience, including Executive, Sr. Executive, Officer, and Sr. Officer, these roles are essential for ensuring compliance and facilitating regulatory submissions across key global markets, including the US, Europe, and ROW (Rest of the World). If you have a strong background in regulatory affairs and are looking to advance your career with a leading pharmaceutical company, this opportunity at Hetero Labs could be the perfect fit.
Job Overview:
- Department: Regulatory Affairs – API
- Positions: Executive, Sr. Executive, Officer, Sr. Officer
- Experience Required: 2-8 years
- Location: HRF, Balanagar, Hyderabad
Position Details:
- Regulatory Affairs – API (US, Europe)
- Position: Executive, Sr. Executive
- Experience: 4-8 years
- Responsibilities:
- Prepare and review regulatory submissions for the US and European markets.
- Ensure compliance with FDA and EMA guidelines.
- Manage lifecycle management activities for existing products.
- Collaborate with cross-functional teams for required documentation.
- Monitor regulatory changes and update processes accordingly.
- Regulatory Affairs – API (ROW)
- Position: Officer, Sr. Officer
- Experience: 2-4 years
- Responsibilities:
- Support regulatory submissions for ROW markets.
- Prepare and compile technical dossiers.
- Assist in responding to regulatory queries and maintaining compliance.
- Work closely with R&D, Quality Assurance, and Production teams.
- Keep track of regulatory requirements and ensure timely submissions.
Key Qualifications:
- Educational Background: Degree in Pharmacy, Chemistry, or a related field.
- Experience: Relevant experience in regulatory affairs, particularly in API submissions.
- Skills:
- Understanding of regulatory guidelines for the US, Europe, and ROW markets.
- Proficiency in preparing and reviewing technical documents.
- Strong communication skills and attention to detail.
- Ability to work in a fast-paced, deadline-driven environment.
How to Apply: Send your updated profile to vivek.s@hetero.com
How to Apply
If you meet the qualifications and are interested in applying for a position in Regulatory Affairs – API at Hetero, please send your updated profile to vivek.s@hetero.com
