- Full Time
- Hyderabad, Telangana
Website Cronus Pharma
Be part of a dynamic and fast-growing team in the veterinary pharmaceutical industry.
Job Title: Injectable Formulation Specialist
Cronus Pharma, a leading veterinary pharmaceutical company based in New Jersey, is dedicated to delivering innovative and cost-effective solutions to the animal health market. Our team, with vast experience in both human and animal health industries, is expanding, and we are looking for talented professionals to join us in our Hyderabad facility.
Roles & Responsibilities:
- Prepare dossiers to support new/original product registrations, focusing on Injectables and Solid Oral Dosage forms.
- Conduct gap analysis of technical documents received from cross-functional teams (CFT).
- Coordinate submission requirements with various departments, including R&D, QA, QC, and Production.
- Review product labeling for compliance.
- Assist in managing the Registration Life Cycle.
- Actively participate in pre-development activities with R&D.
Required Skills:
- Prior experience with US regulatory submissions is essential; experience with EU submissions is a plus.
- Strong knowledge of FDA, cGMP, ICH, and DMF guidelines for regulatory submissions.
- Hands-on experience in CMC submissions and supplemental applications; label experience is an advantage.
- Excellent written and verbal communication skills.
- Ability to work independently with minimal supervision.
- Strong analytical and problem-solving abilities.
- Proficiency with database and compliance software.
- Proficiency with Microsoft Office Suite or similar software.
Experience & Qualifications:
- M.Pharmacy / M.Sc. / B.Pharm or a science-related background.
- 5 to 6 years of experience in Regulatory Affairs of finished dosage formulations, primarily for USFDA and EU markets.
Walk-in Interview Details:
Date: August 11th, 2024
Time: 09:30 AM to 4:00 PM
Venue: Cronus Pharma Specialties India Pvt Ltd,
Plot No: 1-98/5/78, Jubilee Enclave,
Madhapur, Hitech City, R R (D), Hyderabad, Telangana – 500081
Join us at Cronus Pharma and be a part of a team that’s making a difference in animal health.
- For more articles, Kindly Click here.
- For pharmaceutical jobs, follow us on LinkedIn
For more jobs, kindly visit our job section.