Regulatory Affairs Executive - Vadodara, India - Amico Formulations LLP

Amico Formulations LLP

Verified Company

Vadodara, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Post:
RA Executive

Experience:
5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation)

Location:
Vadodara

Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries 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 Information's) 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 timeframes.
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.
Prepare and compliance of Modules-I as per regulatory requirement.