Assistant - Regulatory Affairs, ACG Capsules

Ensure compliance to all regulatory norms (new & existing)

Prepare & submit Drug Master files in CTD format for the respective regions on annual & biannual basis along with issuance of LOA

Handling customer questionnaires / specification on timely manner

Respond to customer / regulatory queries within pre-defined timelines

Conduct regulatory checks of shades & artwork

Obtain / renew regulatory certificates on timely manner

Product – wise ARTG filing in Australia as per timelines and ensure FTR

Generate & maintain regulatory back-up data to respond to regulatory/customer queries

Preparation & maintenance of regulatory documentations for existing and new products

Provide change notifications to customers as and when required

Check and release dossier in DMS on timely basis

Provide regulatory support to Plant QA and International RA teams as and when required

Verify regulatory acceptance of various ingredients in various countries for existing and new products

Maintenance and updation of data in internal online systems

Publication of regulatory updates in order to create awareness among internal stakeholders

Train CSR team and Plant associates (if required) on regulatory requirements

****Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.

Key Result Areas

Timely resolution of customer / regulatory queries (FTR)

Timely submission of regulatory filing for existing products

Renewal of regulatory certificates for existing & new products on timely manner

Key Interfaces

CSR

Sales (TIC)

Plant Quality & Operational

Customer

Certification Agency

Regulatory Agency