With the incorporation of the company in 1987, RHYDBURG dominated the market with an ocean of its products and services. The company today boasts its state of the art manufacturing plant in Dehradun, India that spreads across a sprawling area of 7000 meters. The plant is equipped with the latest machinery and equipment assisting in effective production. The inclusion of some advanced machinery in the plant has assisted in the further growth of our profit levels up to 50-70%. This exponential growth in the company’s graph helped us in multiplying the client base and more importantly, market presence. With the back-up of highly experienced staff and in-house QA and QC labs, a regular analysis of our products including Tablets, Capsules, Topical Preparations, Lotions, Liquids, Orals, Drops, External, Ayurvedic, Dry Syrups, in both Beta-lactum, and Non- Beta lactum is done.
Post: Executive Regulatory Affairs
Job Description:
• Responsible for coordination, preparation, compilation and submission of regulatory dossiers, which shall include preparation of dossiers for CIS, Asian and African countries for Parentrals, Tablets, HGC, Oral, Externals.
o Dossier as per the Guidelines.
o Responsible for preparation of Patient Information Leaflet (PIL).
o Compilation and review of Stability study report of finished and active.
o Preparation of Raw Material Specification, Finished Product Specification, Certificate of Analysis of Raw Material and Finished Product, Stability Data for Raw and Finished Product.
• Checking the Product Designs/Labelling and ensuring they comply with regulatory guidelines.
• Follow up for queries related to dossiers. To keep track of pending Queries from RA from various countries and do time bound follow UP.
• Ensure compilation and internal review of regulatory dossiers as per schedule and their timely submissions.
• Preparing application for COPP and FSC
• Preparing application for export NOC from DCGI
• Follow up with regulatory bodies.
Additional Information:
Experience: 2-5 years
Location: Delhi
Education: B.Pharm
Compensation: 1.25 - 2.25 lakhs / anum
Functional Area: DRA
End Date: 25th Jan, 2012
Rorward your CV to, akshay@rplmail.com
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