Company Overview
Cronus Pharma, a rapidly growing veterinary pharmaceutical company based in New Jersey, seeks a Regulatory Affairs Specialist.
Position: Regulatory Affairs Specialist
Location: Hyderabad, Telangana
Salary: Not disclosed
Qualification: M.Pharmacy / M.Sc. / B.Pharm
Experience: 5 to 6 years in Regulatory Affairs
Roles & Responsibilities:
| Responsibility |
|---|
| Prepare dossiers for new/original product registrations (Injectables & Solid Oral Dosage forms) |
| Perform gap analysis of technical documents from cross-functional teams (CFT) |
| Coordinate with CFT (R&D, QA, QC, Production) regarding submission requirements |
| Review product labeling |
| Support in managing the registration lifecycle |
| Contribute to pre-development activities with R&D |
Required Skills:
- Knowledge of US and EU regulatory submissions
- Familiarity with FDA, cGMP, ICH, DMF guidelines
- Hands-on experience in CMC submissions and supplemental applications
- Experience in label work is advantageous
- Excellent communication skills
- Ability to work independently
- Strong analytical and problem-solving skills
- Proficient with database and compliance software
- Proficient with Microsoft Office Suite or similar software
Walk-In Interview Details:
| Date | Time | Venue |
|---|---|---|
| August 11, 2024 | 09:30 AM to 4:00 PM | Cronus Pharma Specialties India Pvt Ltd, Plot No: 1-98/5/78, Jubilee Enclave, Madhapur, Hitech City, R R (D), Hyderabad, Telangana – 500081 |