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.
Post : Regulatory Affairs Executive
No of Posts : 05
Qualification & Experience : M.Pharmacy/ M.Sc / B.Pharmacy with 4 - 5 Years experience
Job Description
• Responsible for the preparation and meticulous review of all pertaining technical documents required for USED A filings especially Module- 2, 3 in e-CTD format for CVM.
• Responsible for preparation and review of Batch production control records, stability protocols, submission protocols, Submission batch summary reports, stability data and stability reports for ANADA submission batches.
• Responsible for Support regulatory affairs activities in ANADA filings
• Responsible to support technical data for ANADA filings and Responsible for support to address responses for query from customers and regulatory agency.
• Responsible for review of change controls and deviations and their assessments required for submission batches and to address the responses from customers and regulatory agency.
• Coordinate with concerned departments like Quality Control, Quality Assurance, Manufacturing and Research Development for compilation of technical data for dossiers and meet the submission timelines.
• Review of Technical documents Like Product development report, APR , API Tech packages/ DMFs,
• Responsible for preparation and review of Post approval stability protocols and annual report and its supplements.
• Review of documents like API, In-Process, Finished Product and Excipients and packing material specifications and STPs.
• Review of documents like process validation protocols and reports.
• Review of stability study protocols and reports (Long term, Intermediate, Accelerated).
Work Location : Shamshabad
Interested Candidates share their CV's to Mail ID: - planthr@cronuspharma.com
LAST DATE: 4th June 2022
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Hyderabad Alerts
See All Other Jobs in our Database
.png)
