Preparation of registration Dossier as per Common Technical Documents, and country specific guidelines (FORMULATIONS).
Filling of questionnaire to participate in international tenders.
Arranging for Samples of finished product, working standards, reference standards for registration.
To respond to queries received from various Ministry Of Health and other authorities after submission of dossiers.
Preparations of all documents required for sample sending to party like invoice, certificate of analysis,packing list, MSDS, declaration letter, non hazardous certificates etc.
Co-ordinate with quality assurance, Quality control, Analytical development & R& D departments for collecting & reviewing technical documents such as Analytical Method Validation, Process Validation, Stability data, finished product specification, Active & Inactive ingredients Specifications, packing materials specifications, packing material samples.
Sending documents legalization and notarization for registration.
Arranging Samples as per registration requirements for different countries.
Preparation /Review of labelling& Packaging material, packing insert.
On-line application to FDA for new product permissions, FSC, GMP, NCC, MMC, Performance Certificates, COPP etc. (Training will be given).
Preparation of documents for domestic tenders.
Employement Category:
Employement Type: Full time Industry: Pharma / Biotech Role Category: Legal Support Services Functional Area: Not Applicable Role/Responsibilies: Regulatory Officer