Regulatory affairs Officer - Gurugram, India - Coral Drugs. Pvt. Ltd.

Description

Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.

Submission of technical data package and Applicants Part for semi-regulated markets

Submission of response to deficiencies received from authorities and customers

Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets

Use of eCTD softwares and submission gateways like ESG & CESP

Providing regulatory inputs in early development phase of APIs

Review of change controls and technical data required for DMF submissions

Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF

Preparation of LOA and commitment and data management

Submission of change notification for customer.

Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps

Maintenance of database for regulatory submissions including customer notifications

Well versed with current regulatory guidelines.