Regulatory Affairs Executive Job Vacancies in Vadodara

Vega Biotec Pvt Ltd forms part of Vega group companies having state of the art manufacturing company in Vadodara and having presence in over 20 countries. Our export arm has an opening for the following post.1. Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,B.pharma/M.pharmaExperience- Minimum 4 years in RAJob Profile-1. CTD or ACTD dossier preparation for ROW market.2. Coordinating with internal assistant team members for ongoing QA related work.3. Meeting regulatory requirements as per country requirements.

Regulatory Affairs ExecutiveLocation: Vadodara, GujaratMust have Experience in Pharma Industry Must have experience in handling regulatory affairs for ROW market mainly Central and Latin America and Africa for Pharma Formulations. Preparation, Compilation & Review of Registration documents that include Administrative & Technical. Reviewing the technical documents provided by QA, QC, Production. Providing them the report of shortcomings & ensures them to correct the documents. Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data. Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation. Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies. Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames. Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner. Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team. Fill up customer questionnaires by collecting information from various concerned departments. You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time. Maintenance of the complete history of each drug product