Virchow Biotech is a globally recognized pharmaceutical and biotechnology company specializing in injectable products, vaccines, and biologics. With a strong presence in domestic and international markets, Virchow Biotech is committed to innovation, quality, and regulatory compliance. The company offers a dynamic work environment with opportunities for professional growth in regulatory affairs, manufacturing, and R&D.
Job Description (Regulatory Affairs – ROW/NRA – Injectable)
The ideal candidate will be responsible for handling regulatory submissions, compliance, and documentation for injectable products in ROW (Rest of World) and NRA (National Regulatory Authority) markets.
Key Responsibilities:
- Regulatory Submissions:
- Prepare and submit Retention License applications (SUGAM & NSWS portal).
- Handle institutional sales/tender documentation.
- Obtain legal documents from DCA, Hyderabad, and CDSCO.
- Licensing & Compliance:
- Manage grant and renewal of Loan Licenses.
- Prepare and submit WHO-GMP certificates (COPPs).
- Handle additional product submissions for regulatory approvals.
- Manufacturing Approvals:
- Submit and renew Test Licenses (DCA).
- Process Manufacturing License applications for injectable products.
- Daily Tasks:
- Coordinate with regulatory bodies for approvals.
- Maintain compliance with global regulatory standards.
Desired Skills & Qualifications:
- Education: Any Postgraduate degree with excellent communication skills.
- Experience: 4-6 years in regulatory affairs (preferably in injectables).
- Skills: Strong documentation, presentation, and regulatory submission expertise.
- Preference: Immediate joiners will be prioritized.
How to Apply?
Interested candidates can share their updated resume with:
P. Raghurami Reddy
Asst General Manager – HR
📧 Email: raghu@virchowbiotech.com
📍 Company: Virchow Biotech Pvt Ltd, Hyderabad
