Junior Submission Publisher

Title Junior Submission Publisher Business Unit Regulatory Operations - Global Regulatory Business Continuity - Innovative Medicines Job Grade Senior Executive G11B Location Mumbai preferred Gurugram Vadodara Key Responsibilities 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 Position Summary - Job Purpose The Junior Submission Publisher will be responsible for assisting in the compilation formatting publishing and validation of regulatory submissions in eCTD and non-eCTD formats The role will provide exposure to global regulatory submission requirements for agencies such as US FDA EMA Health Canada MHRA and others Key Responsibilities Assist in publishing regulatory submissions NDA ANDA BLA MAA variations supplements IND DMF etc in eCTD and NeeS formats Support preparation of submission-ready documents by ensuring compliance with global health authority specifications and internal publishing standards Perform document formatting bookmarking and hyperlinking in accordance with agency requirements Execute validation checks using publishing tools to ensure submissions are compliant no validation errors Assist in timely delivery of submissions to global health authorities through electronic gateways e g ESG for FDA CESP for EMA etc Maintain archival and version control of submission packages in regulatory systems Collaborate with regulatory operations leads submission managers and medical writers to ensure smooth publishing workflows Support troubleshooting and resolution of technical issues in submission files Stay updated with changes in eCTD specifications guidance and publishing tools Qualifications Skills M Pharm Pharmaceutics Regulatory Affairs Pharmaceutical Sciences Basic knowledge of CTD eCTD structure and global submission requirements Familiarity with publishing tools e g Lorenz DocuBridge Extedo Liquent etc is desirable Strong attention to detail and ability to work under tight timelines Good communication and team collaboration skills Proficiency in MS Office applications and Adobe Acrobat for document handling Travel Estimate Low Job Requirements Educational Qualification Master s degree in Pharmacy M Pharm or Life Sciences Experience 3-5 years in regulatory publishing experience 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