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Evolet Healthcare Pvt. Ltd. is hiring for the position of DRA Executive/Sr. Executive- Drugs Regulatory Affairs.

Job Description:

Role Overview:

The Regulatory Affairs Executive / Sr. Executive will oversee dossier preparation, submission, and product life cycle management in CTD/ACTD formats, ensuring compliance with ICH guidelines. The role involves handling MOH queries, coordinating with global markets, and supporting regulatory processes across CIS, ASEAN, LATAM, and African regions.

Key Responsibilities:

- Need to work on DRA regular work.
- Dossier submission for fresh and re-registration products.
- Product life cycle management.
- Queries response within timeframe.
- Must be able to coordinate with team and partner plants to achieve targets.
- Controlling the whole process of registration product from beginning till the end.
- Should have experience of dossier format like (CTD & ACTD), regional / country specific.
- Should have experience on markets like CIS, ASEAN, LATAM and AFRICAN countries.
- Good knowledge of ICH guidelines required.




- Open to give trainings to team for required topics.
- To be flexible for travelling and meeting with manufacturing plant representatives, which located out of station.

Mandatory Skills and qualifications

- Preferably 2-6 years of experience in DRA Department.
- Experience with ACTD/CTD Dossiers.

Desired skills

- Exposure to Drug Regulatory Affairs.
- Good Knowledge of ICH guidelines.
- Technically Comprehensive.
- Fine Analytical Skills and Systematic approach.
- Proactive approach to problem solving.
- Thorough Knowledge of GMP Practices.
- Engrossment in job related work-enjoying his work.
- Good computation Skills.
- Strong and consistent.
- Logical Interpretation of Data.
- Ability of multi-tasking.
- Fluent in English (Speaking, writing, reading and understanding)
- Computer Skills (Ms. Excel, Ms. Word, Internet, Email)

What We Offer:

- Friendly and supportive work environment
- PF benefit
- Medical Health Insurance
- Rewards and Recognition and appreciation
- Market-competitive salary and benefits
- Growth and learning opportunities

📌 DRA Sr. Executive/Executive (Gurugram)
🏢 Evolet Healthcare
📍 Gurugram