Gurgaon

Job Description Job title Asst. Manager – Regulatory Affairs – Gurgaon Reports to Director   Job purpose To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMS documentations, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. This […]

Job Description Job title Asst. Manager – Regulatory Affairs – Gurgaon Reports to Sr Manager/Project Lead Job purpose To Manage Regulatory Affairs for global Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMC documentation, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis.

Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical