**Position :** Executive / Sr Executive **Grade** : G11A/ G11B **Job Location** : Gurgaon (preferable)/Baroda/Mumbai **Education** : M.Pharm **Department** : Regulatory & Business Continuity - Branded Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) who shall be responsible for regulatory operations activities including but not limited to CTA applications(in EU, LATAM , USA, Canada, ROW) , CTIS management, submission management, eCTD publishing of all modules, document management etc. Must understand and be updated with current Global Regulatory filing requirements and eCTD /CTIS structure. + Collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. + Prepare Regulatory Management Plan, Submission content plan for CTA + Manage lifecycle of CTA for all in-house and outsourced activities + Be the critical technical coordinator for Clinical Trial Application submission and notification/ Request for Information/Information request ensuring accurate and timely input of data + Archival of necessary submissions and/or documents + Assist with definition, development and implementation of processes to meet the evolving CTIS need + Track, generate metrics as requested by the Functional Head from time to time + Implement best practices, participate in process improvements / enhancement To support other Regulatory operations activities including, but not limited to, Clinical Trial Disclosure, eCTD publishing We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.