Senior Executive - Regulatory Affairs

Job Description

Work Experience

Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements.  Preparation of CMC sections, compilation and review of dossiers as per country specific requirements.

Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe.

Preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline.

Coordination with inter departments (QA, QC, R&D, MSAT etc.) for source documents required for various regulatory submissions. · Preparation and maintenance of product specific TRACKERS. · Continually track any changes, variations or process modifications throughout product life cycle and carry out necessary update to documentation in order to comply with all norms.

The above list is not exhaustive and may be assigned additional responsibilities from time to time. In the absence, the above Job Responsibilities shall be done by competent / trained personnel from team.

Education

Competencies