Regulatory Affairs

Department: Regulatory Affairs

Experience: 3 years to 6 years

Job Responsibilities

Preparation, review and planning of submission of CTD/ACTD/ECTD for export market

Floating of official email for technical documents and queries reply

Prepare/monitoring site registration documents for export market

Registration / Re-registration / post approval changes application for export market

Resolve the technical query related to product registration / Re-registration / post approval changes

Follow-up and coordination with internal stake holder ( QA, QC, R&D, Technical services

Department, production, packing, account, purchase & business development)

Review of technical documents, Process validation, Stability data, Analytical method validation,

Product development report, finished product specification, Qualitative Quantitative formula

Standard testing procedure, batch manufacturing record, batch packing record, certificate of

Analysis, container and closure system and open part Drug master file

To intimate & review of BE study from Approved BE center

Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis

To prepare monthly regulatory status report and status of new registration / Re-registration / post approval changes

Coordination with stakeholder for collecting documents for preparation of dossier, review of

dossier and submission to respective regulatory authority

Review of artwork and pack insert as per rules laid by respective regulatory authority

Preparation and submission of Product safety update report

Coordinate the renewal of FDA license (GMP, COPP, manufacturing license, wholesale)