Senior Submission Publisher

Title Senior Submission Publisher Business Unit Regulatory Operations - Global Regulatory Business Continuity - Innovative Medicines Job Grade G10 Manager Location Mumbai preferred Gurgaon Baroda 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 Job Purpose The Senior Submission Publisher will lead and oversee the planning preparation publishing and dispatch of regulatory submissions in eCTD and non-eCTD formats to global health authorities This role not only ensures submission compliance and quality but also provides leadership in workload management publishing strategy and adoption of new tools and technologies to streamline the submission process Key Responsibilities Core Publishing Oversee end-to-end publishing activities for major and minor submissions NDA ANDA BLA MAA IND DMF variations renewals supplements Ensure compliance with global health authority requirements FDA EMA Health Canada MHRA TGA WHO etc Perform document formatting hyperlinking bookmarking and validation using industry-standard publishing tools Ensure on-time dispatch of submission packages via electronic gateways e g ESG CESP MHRA portal Quality Compliance Conduct quality reviews of submissions prepared by junior publishers ensuring adherence to specifications and eliminating validation errors Maintain submission archives version control and audit-ready documentation Implement best practices and continuous process improvements to strengthen publishing quality and compliance Workload Team Support Manage daily workload distribution within the publishing team to meet timelines Provide guidance and technical support to junior publishers and new team members Act as the first point of contact for troubleshooting complex publishing issues Metrics Process Improvement Generate and track submission metrics cycle times on-time delivery volume quality compliance for management review Identify opportunities for process optimization and automation within publishing workflows Support development and refinement of Standard Operating Procedures SOPs and work instructions Technology Innovation Participate in testing validation and implementation of publishing tools version upgrades Provide feedback to IT and system vendors in enhancing publishing tool functionality Stay updated on emerging regulatory publishing trends specifications and technologies Qualifications Skills Master s degree in Pharmacy M Pharm or Life Sciences preferred 6-10 years of hands-on regulatory publishing experience in eCTD and non-eCTD formats Expertise in CTD eCTD structure regional specifications and global submission requirements Proficiency with industry-leading publishing tools Lorenz Liquent Extedo Veeva Vault Amplexor etc and validation tools Strong attention to detail organizational skills and ability to manage multiple priorities Good leadership and team mentoring skills Excellent written and verbal communication skills Experience in metrics generation process improvement and tool implementation preferred Experience in RIMS Implementation Regulatory Data Management and Governance will be an added advantage Travel Estimate Low Job Requirements Educational Qualification Master s degree in Pharmacy M Pharm or Life Sciences Experience 8 years of hands-on regulatory publishing experience in eCTD and non-eCTD formats 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