Executive - Global Regulatory Operations - Branded
4 days ago
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 you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Key responsibilities Position Executive Grade G12A 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 Travel Estimate 20 Job Requirements Educational Qualification M Sc B Pharm M Pharm 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 Let s 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
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