Hiring for Senior Executive- RA : Gurgaon for a Leading Pharma Co. in Gurgaon, for Exp. 3 - 8 yrs at New Era India Consultancy Pvt. Ltd..
MedWiz Gurgaon, Haryana, India
Feb 19, 2018Full time
Job Description:Dear All, Position will report to : Sr. Manager Regulatory Affiars Qualification : M.Pharm from reputed institute with more than 70% marks Skills : Person should have worked for eCTD filing for injectables and ophthalmics. Cdate should be able to join within a month. Should be a man job-seeker. Should be a North Indian Should have worked in above-average pharma companies. POSITION : Sr. Executive - Regulatory Affairs (regulated Market) SUMMARY OF THE OVERALL JOB : To be in charge of Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region KEY RESULT AREA : Review and submission of ANDA Review and submission of responses to the queries Review of all documents related AD , PD, QA, MA & amp amp Plant KEY FUNCTIONS / DUTIES :& amp nbsp 1. Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region. 2. Initiate the submission of all the dossiers in eCTD format across US and EU. 3. Initiate the submission of eLabeling i.e., SPL and PLR for US market. 4. Review and submit responses for the queries received from the USFDA and EU regulatory agencies. 5. Review and submit the supplements & amp amp variations for filing the post approval changes in the US and EU region. 6. Review the analytical document of raw material and finished products specifications & amp amp test procedures, packaging material specifications & amp amp test procedures, in-process specifications & amp amp test procedures, analytical method validation protocols and reports etc. 7. Review the development documents like master formula records, product development reports and stability protocols etc. 8. Review the plant documents like batch manufacturing records, process validation protocols and process validation reports etc. 9. Make sure that the compliance of the registration dossier in line with the practice at plant. 10. Update the team members by providing various presentations on regulatory topics. EDUCATION : M.Pharm EXPERIENCE : 3+ years of experience in ANDA filing for injectable, ophthalmic / sterile dosage forms