Job title: Submission Manager
Location: Hyderabad

About the job

The Submission Manager applies regional expertise in managing all submission types for the regional GRA portfolio, from standard to complex. The Submission Manager is responsible for the operational submission planning, ability to prioritize workload, and negotiate timelines with key stakeholders. They also partner closely with Publishers/Submission Associates to execute the preparation of the submissions according to plan.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

• Applies project management skills and regulatory knowledge for regional eCTD standard and maintenance submission types.
  
• Applies expert understanding on eCTD dossier formats, standards, navigation and lifecycle management.
  
• Advise stakeholders on eCTD guidance to ensure an appropriate understanding of electronic submission requirements from a cross-functionally perspective, supporting successful submissions.
  
• Direct publishing activities for assigned portfolio to ensure high quality and timely submission delivery aligned to both Sanofi and applicable Health Authority standards.
  
• Acts as Subject Matter Expert (SME) for 1572/CV, TORO, Safety MedWatch + Periodic Safety Reports (PBRER, PADER etc) submission types.
  
• Draft + Review Cover Letters and associated submission application forms.
  
• Partner with GRA and Digital functions as SME for current processes/data/technologies, as well as evaluating and implementing new/emerging technologies and requirements.
  
• May be assigned supervisory responsibilities.
  

• 4 to 6 years of relevant professional experience in Pharmaceutical Industry, with direct experience in Regulatory Operations and/or Regulatory Affairs
  
• High degree of knowledge regarding the eCTD 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.
  
• Expert knowledge of regional submission standards and specifications. Strong understanding of eCTD requirements and submission processes.
  
• Expertise in the eCTD publishing process, document management environments/systems, publishing tools and submission software. Maintain independent abilities to learn quickly and adapt to new technologies/environments.
  
• Self-starter, who is motivated. Ability to work across cultures. Ability to identify and communicate opportunities for process improvement.
  
• Strong attention to detail and accuracy.
  
• Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
  
• Bachelor's degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
  
• High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
  
• 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.