15 Aug
|
HR Footprints
|
Hyderabad
15 Aug
HR Footprints
Hyderabad
Roles and Responsibilities :
- Manage drug regulatory affairs, including dossier preparation, submission, and approvals from US FDA (US Food and Drug Administration).
- Coordinate with cross-functional teams to ensure timely completion of regulatory requirements throughout the product lifecycle.
- Prepare and review variation applications, renewals, and other documentation related to drug regulations.
- Provide guidance on regulatory compliance matters to internal stakeholders.
Job Requirements :
- 5-7 years of experience in pharmaceutical industry with expertise in drug regulatory affairs.
- Robust understanding of USFDA guidelines and regulations governing drug development process.
- Proficiency in preparing dossiers for regulatory submissions, including eCTD format.
📌 Regulatory Affairs Associate (Hyderabad)
🏢 HR Footprints
📍 Hyderabad