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Saturday, September 12, 2015

Executive - Regulatory Affairs Piramal Enterprises - Healthcare by

DesignationExecutive - Regulatory Affairs
Job DescriptionPreparation 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

Experience2 - 3 Years
Industry TypePharma / Biotech / Clinical Research
Functional AreaOther
EducationUG - 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.
LocationHyderabad / Secunderabad
KeywordsRegulatory Affairs RA eCTd Compliance ectd regulatory GMP Compliance
Job Posted2015-09-12 17:24:43.0


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