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 …
Job Description Job title Medical-Regulatory Writer – Assistant Manager Reports to Director Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable Regulatory Guidelines Duties and responsibilities Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. …
Job Description Job title Senior Manager/Team Lead – Regulatory Affairs – Regulated Markets Reports to Director Job purpose To Manage Regulatory Affairs for US Markets in compliance to applicable regulations and guidelines. This position will assist with the preparation and submission of ANDAs, Amendments, Supplements and Annual Reports to appropriate regulatory agencies. This position …
Job Description Job title Senior Manager/Team Lead – Regulatory Affairs – Emerging (RoW) Markets Reports to Director Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets in compliance to applicable regulations and guidelines. This position will oversee the team of 2-5 team members to manage filings in key RoW markets by DDReg. The …
Senior Manager/Team Lead – Regulatory Affairs – Row Markets Read More »
Job Description Job title Senior Manager/Team Lead – Regulatory Affairs – Regulated Markets 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 …
Senior Manager/Team Lead – Regulatory Affairs – Gurgaon Read More »
Job Title: Software Tester Job Description: We are seeking a skilled and motivated Software Tester with at least 1 year of experience to join our dynamic quality assurance team. As a Software Tester, you will play a crucial role in ensuring the quality and reliability of our software products through rigorous testing and validation processes. …
Job purpose To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines. Education & Experience Master’s degree in Pharma discipline. 1-3 years of experience in handling Regulatory Affairs function. Knowledge, Skills and Abilities Excellent technical data interpretation skills. …
Associate – Regulatory Affairs (Gurgaon Location) Read More »
