Company Name: Medreich Limited
Company Website: www.medreich.com
Company Profile: Eureka Forbes is a consumer durable company which was formed from a joint venture between the Shapoorji Pallonji Group’s Aushim Gupta & Company Ltd. based in Mumbai, and Electrolux of Sweden in 1982.
Job Location: Bangalore
Job Location: Bangalore
Job Role: Officer-Regulatory Affairs
Job Experience: 1-3 Years Experience
Job Eligibility: B.Pharma/M.Pharma
Job Summary:
Candidate should be B.Pharma/M.Pharma from a recognized university.
Preparation of quality, non-clinical & clinical overviews for the different classes of products.
Preparation and compilation of module 2, 3, 4 and 5 for the regulated markets in CTD and ACTD format.
Reviewing of quality, Bio-equivalence study and Bio-analytical reports as per the regulatory authority guidelines.
Handling queries on quality, Clinical, Non-clinical and Bio-equivalence parts received from the different ministries.
Preparation of the Summary of Product Characteristics & Patient Information Leaflet as per the different country requirements.
Preparation of Literature references for the Non-regulated & semi regulated markets.
Good Communication skills with the Different CROs.
Preparation of quality, non-clinical & clinical overviews for the different classes of products.
Preparation and compilation of module 2, 3, 4 and 5 for the regulated markets in CTD and ACTD format.
Reviewing of quality, Bio-equivalence study and Bio-analytical reports as per the regulatory authority guidelines.
Handling queries on quality, Clinical, Non-clinical and Bio-equivalence parts received from the different ministries.
Preparation of the Summary of Product Characteristics & Patient Information Leaflet as per the different country requirements.
Preparation of Literature references for the Non-regulated & semi regulated markets.
Good Communication skills with the Different CROs.
Job Skills:
Excellent Communication skills.
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