| Designation | Executive - Regulatory Affairs |
| Job Description | Preparation and compilation of regulatory documents (DMFs / ASMFs) for filing with regulatory agencies and customers. Communication with concerned internal customers to address the technical queries on the dossiers and other regulatory submissions, including marketing related queries. Filling the customer questionnaires, adherence to QA systems and IT policies related to the electronic submissions (DMFs, ASMFs & SPLs) through ESG. Internal audits for regulatory compliance. Updating and organising with Pharmacopeia revisions, track record (electronic & paper) for all registered products. cGMP training-planning, and adequacy of the training. Monthly reports for RA activities. |
| Desired Profile |
S/he should have good exposure in CFR Part-11 compliances,
ICH guidelines, Pharmacoepias, Audit trial reviews and maintenance, investigations, deviation handling etc. S/he should be capable of handling shifts independely and should be willing to reallocate in Zaheerabad |
| Experience | 2 - 3 Years |
| Industry Type | Pharma / Biotech / Clinical Research |
| Role | Other |
| Functional Area | Other |
| Education | UG - B.Sc - Microbiology PG - M.Sc - Microbiology Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required |
| Compensation: | 3,00,000 - 4,00,000 P.A. Free transportation facility from plant to Zaheerabad, Subsidised Canteen, GPA, Medical Insurance for Self + 5 dependants, etc. |
| Location | Hyderabad / Secunderabad |
| Keywords | Regulatory Affairs RA eCTd Compliance ectd regulatory GMP Compliance |
| Contact | HR |
| Website | http://www.piramal.com |
| Job Posted | 2015-09-12 17:24:43.0 |
| Reference | Dig/QC/Micro/B1/150225 Apply |
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