Biocon Biologics Hiring B.Pharm,M. Pharm,Bsc,MSc For Multiple Positions
Biocon Biologics Released Job Openings On 25/10/2022.Biocon Biologics is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.
Vacancy Details:
Biocon Biologics Recruiting B.Pharm,M. Pharm,Bsc,MSc Candidates with 05+ Years of Experience for Team Member – Regional RA position.
Important Details :
- Location : India
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 25/10/2022
- Mode of application :Online
- How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle
Accountabilities
I. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
II. Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
III. Maintain, and update product dossier as required to meet changes in Ciplaï¿Â½Ãƒ¯Ã‚¿Ã‚½Ãƒ¯Ã‚¿Ã‚½Ãƒ¯Ã‚¿Ã‚½Ãƒ¯Ã‚¿Ã‚½Ãƒ¯Ã‚¿Ã‚½s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the informatuitability and availability of dossier for out-licensing and in-licensing
VII. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done
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