L 5 - NDDS/TT
savaglobal
Executive- DRA
savaglobal· Drug Regulatory Affairs
About this role
Job Purpose
To support the Regulatory Affairs function by preparing, compiling, and submitting dossiers for ROW (Rest of World) and EU markets, handling variations, and managing renewals in compliance with applicable regulatory guidelines.
Key Responsibilities
1. Dossier Preparation (ROW & EU)
Preparation and compilation of CTD/eCTD dossiers for ROW and EU markets.
Review and verification of technical documents (Module 1–5).
Coordination with QA, QC, Production, R&D, and other departments for required documentation.
Ensuring submissions comply with guidelines of regulatory authorities such as European Medicines Agency and respective country regulations.
Handling deficiency queries and preparing responses within stipulated timelines.
2. Variation Management
Preparation and submission of variation dossiers (Type IA, IB, Type II as applicable).
Tracking variation approvals and implementation timelines.
Maintaining updated records of approved variations.
3. Renewals
Preparation and submission of renewal dossiers within regulatory timelines.
Coordination for updated documents required for renewals.
Tracking renewal status and maintaining regulatory database.
4. Regulatory Compliance & Documentation
Maintaining regulatory trackers and submission databases.
Ensuring document archival as per SOPs.
Supporting audits and inspections related to regulatory documentation.
Educational Qualification
B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)
Experience
2–5 years of experience in Regulatory Affairs.
Hands-on experience in ROW and EU dossier preparation.
Experience in handling variations and renewals.
Key Skills & Competencies
Strong knowledge of CTD/eCTD format.
Understanding of EU and ROW regulatory guidelines.
Good documentation and coordination skills.
Attention to detail and timeline management.
Proficiency in MS Office and regulatory software tools.
Frequently Asked Questions
Is the salary disclosed for the Executive- DRA position at savaglobal?
The salary for this Executive- DRA role at savaglobal is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Executive- DRA position at savaglobal located?
This Executive- DRA role at savaglobal is based in Pune, MH, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Executive- DRA role at savaglobal full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Executive- DRA role in the Drug Regulatory Affairs department at savaglobal.
Which team or department does the Executive- DRA at savaglobal belong to?
This Executive- DRA position is part of the Drug Regulatory Affairs department at savaglobal. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Executive- DRA position at savaglobal?
Click the "Apply Now" button on this page. You will be redirected to savaglobal's official application portal hosted on keka where you can submit your application directly.
When was the Executive- DRA job at savaglobal posted?
This Executive- DRA position at savaglobal was posted on Jul 15, 2026. Apply as soon as possible — early applications are often reviewed first.
Executive- DRA
savaglobal
You'll be redirected to savaglobal's official application page on keka.