Cronus Pharma is a fast-growing, privately held veterinary pharmaceutical company located in New Jersey, dedicated to providing innovative and cost effective products to the animal health market. Our team of seasoned industry professionals have been intimately involved in the establishment, and growth of several pharmaceutical manufacturing, and distribution firms in both the human and animal health pharmaceutical industries.
Walk-in Interview- Injectable Formulation
Roles & Responsibilities
• Preparation of the Dossier in support of new/original product registrations (Injectables & Solid Oral Dosage forms).
• Perform gap analysis of technical documents received from CFT.
• Coordinate with CFT (R&D, QA, QC, Production etc.) regarding all submission requirements.
• Product Labeling review.
• Support in management of Registration Life Cycle.
• Actively contribute in pre-development activities with R&D.
Required Skills :
• Prior knowledge and experience of US regulatory submissions (main requirement) and EU submissions is desired.
• Knowledge of FDA, cGMP, ICH, DMF guidelines for regulatory submissions
• Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage.
• Excellent written and verbal communication skills
• Ability to work independently within minimal supervision.
• Excellent analytical and problem-solving skills.
• Proficient with applicable database and compliance software
• Proficient with Microsoft Office Suite or similar software.
Experience & Qualification :
M.Pharmacy / M.Sc. / B.Pharm or science background
5 to 6 years' experience in Regulatory Affairs of Finished dosage formulations mainly for USFDA, EU
Walk in Interview
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
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