My MNC Client is looking for Regulatory Affair officers with EU /US Market Exposure . Kindly Find below details Position - Sr. Officer / Executive / Sr. Executive / Assistant Manager Department : Regulatory Affairs EU ,US & ROW Market Location - Mumbai (Andheri) Qualification- BPharma / MPharma CTC- Upto 8Lacs only Experience- 3-8Years and Responsibilities To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirement Should have good experience in renewals of Documentation Knowledge of Initial filling and post approval activities for all modules M1-M5 Should Possess knowledge for CMC Section Update, Reviewing part ,Submission of documentation To write, check/review of documents as per regulatory requirements 6-8 years\' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Kindly send me your updated CV on [HIDDEN TEXT] Current & Expected CTC Notice Period Total Experience Kindly refer your friends / colleagues who are looking out for job change. Warmly, Vishakha Ghadi - HR Recruiter Sharp Point HR Consulting, Email- [HIDDEN TEXT] Mobile- 9136904683
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