Regulatory Affairs-Injectables, Hyderabad
Here are the details of Regulatory Affairs-Injectables job in Dr. Reddys Laboratories Ltd. This job or placement paper has been sourced from either company website or newspaper or other media and from students who appeared for this job. User is requested to verify the data before applying for the job.
Participate in the regulatory activities of full spectrum of formulation development, from clinical trials to marketing to post approval activities. •Ensure the appropriate licensing, marketing and legal compliance of the finished dosages. •Review the documents at each stage of formulations development. •Highlight the regulatory issues that can be there and try to resolve them. •Coordinate with R&D, AR&D, QA, etc. to collect the complete set of documents. •Compile the document to be submitted to Europe Markets. •Ensure the documents are error free and have minimum deficiencies. •Manage change controls and deviation controls. •Keep themselves abreast of international legislation, guidelines and customer practices •Develop and write clear arguments and explanations for new product licenses and license renewals. •Advise PDTs on regulatory requirements. •Respond to the queries of Regulatory authori
Skill Set Required
M.Pham with experience in compilation of dossiers on injectables and steriles for US/Europe markets
Experience:- 2 - 6 Years
Education:- UG - B.Pharma - Pharmacy
Functional Area:- Engineering Design, R&D
About Dr. Reddys Laboratories Ltd:-
Dr. Reddy's Laboratories Ltd was established in 1984. It is an integrated global pharmaceutical company.
Dr. Reddy's Laboratories Ltd offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), Custom Pharmaceutical Services (CPS), Generics, Biosimilars, Differentiated Formulations and News Chemical Entities (NCEs).
Why Dr. Reddy's Laboratories Ltd:-
Dr. Reddy's Laboratorie is one of the most HR positive companies in the sector. It is progressive work place for Employees.
Dr. Reddy's Laboratories Limited
Door No 8-2-337,
Road No 3, Banjara Hills,
Hyderabad - 500034.
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