Job title: Senior Publisher
Location: Hyderabad

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Junior Publisher within our Global Regulatory Operations Team you'll be responsible for coordinating lifecycle submissions for the regional portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA specifications. You will also partner with corresponding Submission Managers and Submission Leads to support the publishing and delivery of complex submission plans. You have accountability for 3rd party publishing interactions, training, QC and workload prioritization. The Senior Publisher also provides publishing subject matter expertise to project/product teams, special projects, and continuous improvement initiatives.

• Flexibility to work 3 pm - 11 pm local time collaborating with a team based in North America
  
• Coordinate lifecycle submission requests for the regional portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA specifications.
  
• Prepare and compile regional submission documentation to regulatory health authorities according to ICH / eCTD format and submission ready health authority standards, as well as Sanofi standards.
  
• Ensure end-to-end process adherence for routine compliance submissions.
  
• Perform quality control checks for submission publishing, understanding, and addressing validation criteria in detail, and troubleshooting.
  
• Assist in improvement efforts of publishing processes and contribute to review and updates of quality documents.
  
• Identify and raise submission technical issues in timely manner to ensure that resolutions are realized, enabled, and executed to deliver according to planned submission filing dates.
  
• Maintain knowledge of regulatory requirements for document and submission assembly and publishing across various submission regions on a continuous basis.
  

• 3 to4 years of relevant professional experience in Pharmaceutical Industry, with direct experience in Regulatory Operations
  
• Ability to identify critical issues and propose creative and achievable solutions through using appropriate information.
  
• Determine the causes and possible solutions to identified electronic errors/issues.
  
• High degree of technical knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
  
• Proficiency working in eCTD publishing tools, RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
  
• Self-starter, who motivates and negotiates with an agile and positive approach.
  
• Strong attention to detail and accuracy. Ability to work across cultures.
  
  
• Bachelor's degree or equivalent degree in regulatory affairs, the sciences, or related areas of study, and relevant experience.
  
• Strong command of the English language, both spoken and written
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.