Officer / Executive - Regulatory Affairs - API SUN PHARMA - MUMBAI, INDIA Qualification - Bsc, Msc, Mpharm Experience - 4 to 9 years of experience in API Regulatory Affairs 1. Preparation and Execution of Drug Master files of API in CTD and ECTD format, independently in coordination with plant people. 2. Checking and reviewing of documents required for DMF filing received from plant for its thoroughness and getting corrections done from plant , independently. 3. Handling to DMF deficiencies Preparation of action plan and deficiency responses Timely Response of DMF deficiencies in coordination from R&D, Plant , ADD 4. Annual updates of DMF and renewal applications for CEP . 5. Completion of QA and ISO questionnaire received from customers in coordination with plants. 6. Helping API plants for the preparation of audits from Regulatory Agencies, in case required . 7. Moving to API locations for checking and collection of documents as and when required . linkedin/jobs2/view/9327114
Posted on: Sun, 03 Nov 2013 15:42:02 +0000
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