Regulatory Affairs Jobs in Vadodara,Regulatory Affairs Job Vacancies in Vadodara Gujarat

Regulatory Affairs Officer

Renown Pharmaceutical Pvt Ltd

0 - 2 yrs
3.3 Lac/Yr
Vadodara

Regulatory Affairs Pharma Life Sciences

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Timely compile materials for license renewals, updates and registrations. Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners. Review labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory re-portability Responsible for timely registration of the facility Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required

View all details

Apply

Regulatory Affairs Executive

Vega Biotec Pvt Ltd

VB

3 - 7 yrs
4.8 Lac/Yr
Vadodara

Drug Regulatory Affairs Pharma

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.

View all details

Apply

Regulatory Affairs Executive

Amico Formulations LLP

AF

6 - 8 yrs
4.8 Lac/Yr
Vadodara

Communication Skills Pharmacovigilance Drug Regulatory Affairs Pharma

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

View all details

Apply

Regulatory Affairs Job Vacancies in Vadodara

Regulatory Affairs Officer

Regulatory Affairs Executive

Regulatory Affairs Executive

Apply to 3 Regulatory Affairs Job Vacancies in Vadodara