Executive Global Regulatory Operations Branded

Job Title
Executive Business Unit Global Clinical Operation Job Grade G12A Location : Gurgaon/Mumbai At Sun Pharma, we commit to helping you ?Create your own sunshine?? by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community, Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, youll find yourself becoming ?Better every daythrough continuous progress Exhibit self-drive as you ?Take chargeand lead with confidence Additionally, demonstrate a collaborative spirit, knowing that we ?Thrive togetherand support each others journeys? Key Responsibilities Position : Executive Grade : G12A Job Location : Gurgaon (preferable)/Baroda/Mumbai Education : MPharm 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 Travel Estimate 20% Job Requirements Educational Qualification Sc / B Experience Tenure : 1 to 3 Years Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact Lets create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s),