3 Days Left Executive

4 days ago

Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

Job Title Senior Executive Manager 2 - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G11A G11B Location Baroda 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 Job Summary Regulatory submission of new products variations response to queries Life cycle management for ASEAN markets mainly Thailand through preparation of quality dossiers enabling timely approvals Area Of Responsibility 1 New submissions a Should be well-versed with country-specific requirements b Active participation in Regulatory strategy for new filings and LCM c Review prepare CMC Chemistry Manufacturing and Controls dossiers for fresh submissions d Review documents Development report scale up report specification stability protocol artworks etc before initiation of Exhibit batches for adequacy 2 Approval Review prepare response to deficiency enabling approval of products filed to regulatory agency 3 Lifecycle management for drug formulations a Prepare and review variations as per the country requirements to support approval of changes such as API vendor changes changes in ROS test parameters DF site changes harmonization of products etc b Prepare and review re-registration PCH dossiers submit the same to regional office regulatory agencies 4 Regulatory compliance a Prepare Review and circulate approval package to stake holders upon receipt of approval and update the same based on queries and variations b Ensure reposition of comprehensive product information into central repository C Review regulatory filing impact of variations change controls etc Travel Estimate NA Job Requirements Educational Qualification M Sc M Pharm Experience Tenure 2-8 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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