Executive - Regulatory Affairs
1 - 5 YearsBengaluru/Bangalore
Job Description
reparation & Review of Registration Dossiers as per either of US/European Union/CANADA/Australia requirements (In CTD format).
Preparation of Module-3 and Module-2 of Registration dossiers in CTD format. [Solid Orals]
Updation of registration dossiers, evaluation of the queries received from respective country agencies.
Review of documents such as product manuals, batch manufacturing records, stability protocols, specifications, validation protocols and Validation reports of process as well as analytical method for regulatory compliance.
Liaison with various departments like R&D, Analytical Development, QC, QA, Production and Corporate affairs
Evaluation of gap-analysis for line-extension products
Handling the query received from various countries and customers
Review the documents as per specific country requirementCompany Profile
Preparation of Module-3 and Module-2 of Registration dossiers in CTD format. [Solid Orals]
Updation of registration dossiers, evaluation of the queries received from respective country agencies.
Review of documents such as product manuals, batch manufacturing records, stability protocols, specifications, validation protocols and Validation reports of process as well as analytical method for regulatory compliance.
Liaison with various departments like R&D, Analytical Development, QC, QA, Production and Corporate affairs
Evaluation of gap-analysis for line-extension products
Handling the query received from various countries and customers
Review the documents as per specific country requirementCompany Profile
Medreich is a pharmaceutical company that has been in existence since 1976, manufacturing generic and branded drugs in several therapeutic areas. With more than 2900 employee's worldwide, exceptional quality standards and a client base that is spread across 54 countries, Medreich has built a reputation for raising the bar on product superiority with every undertaking.
Medreich's Research & Development and manufacturing facilities have received the seal of approval from leading global regulatory bodies such as -UK MHRA, Australia TGA, SA MCC, Health Canada, French FDA. The company produces drugs for leading, global pharmaceutical companies such as GSK, Pfizer, Sanofi Aventis, Wyeth, Merck, among others.
Medreich has 8 manufacturing facilities built to comply International regulatory standards. Two newly added facilities are State of the art technology driven plants. One among them has the capacity to produce 9 billon tablets and capsules per annum.
Medreich's Research & Development and manufacturing facilities have received the seal of approval from leading global regulatory bodies such as -UK MHRA, Australia TGA, SA MCC, Health Canada, French FDA. The company produces drugs for leading, global pharmaceutical companies such as GSK, Pfizer, Sanofi Aventis, Wyeth, Merck, among others.
Medreich has 8 manufacturing facilities built to comply International regulatory standards. Two newly added facilities are State of the art technology driven plants. One among them has the capacity to produce 9 billon tablets and capsules per annum.
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