About Company:
Cronus Pharma is a fast-growing, privately held generic 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. Through our in house R&D and licensing, Cronus brings several differentiated generic products serving both the companion and food producing animal markets. We have a growing portfolio of over 20 products having recently acquired a large product portfolio from one of the leading global pharmaceutical companies in the world. We are dedicated to investing in Research & Development and have an extensive team of scientists developing innovative products. Several products are under development as well as pending FDA approval. Fully licensed in all 50 states to distribute pharmaceutical products, our products are accessible to all veterinarians and pet owners nationwide at major wholesalers and regional distributors. Our passionate team is committed to growing our business and being among the leading veterinary generic pharmaceutical companies in the country.
Website
http://cronuspharmausa.com
Vacancy Details:
Job Description:
We’re Hiring
Walk-in Interview:- Injectable Formulation
Date & Time: Monday to Saturday & 09:30 AM to 4:00 PM
Position: Sr. Executive/Executive
Regulatory Affairs
1.Preparation of the Dossier in support of new/original product registrations (Injectables & Solid Oral Dosage forms).
2.Perform gap analysis of technical documents received from CFT.
3.Coordinate with CFT (R&D, QA, QC, Production etc.) regarding all submission requirements.
4.Product Labelling review.
5.Support in management of Registration Life Cycle.
6.Actively contribute in pre-development activities with R&D.
Required Skills, Experience & Qualification:
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
1.Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage.
2.Excellent written and verbal communication skills
3.Ability to work independently within minimal supervision.
4.Excellent analytical and problem-solving skills.
5.Proficient with applicable database and compliance software
6.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
Send your CV to
Email: hreCronuspharma.com/planthrecronuspharma.com
Interview Location: Cronus Pharma Specialties India Pvt Ltd,
GMR Hyderabad AviatioN SEZ, Mamidipally (V), Balapur (M), HYDERABAD, RANGA REDDY (D), Telangana, -5000108
More Information © HR Ph. No’s : 7337445157/7337445197
