Submissions Manager - 12 month

Job description

Submission Manager - 12 month

What you will have;

The Submissions Manager will have a relevant Bsc with 3 years regulatory affairs experience.

They will have a strong understanding of CMC, Labelling, Clinical, Submission Management, Local RA and have experience managing complex global submissions with in-depth knowledge of global regulatory requirements for major markets.

The ability and willingness to travel internationally (mainly Europe) approximately 10-15% 

What you will do;

  • The Submissions Manager will act as a Project Manager of tasks related to compilation/ publishing of complex global Regulatory submission  
  • They will create and manage cross-functional timelines for global submissions with consideration of key interdependencies 
  • Leading a global (external) publishing team in the context of a given submission 
  • Managing the timely delivery of compliant global submissions 
  • Responsible for technical interactions with global HA, i.e. gateways, validation issues and similar 
  • The Senior Submission Manager lead of Global Regulatory will provide overview/status of submission activities relevant to the team and presenting and highlighting the dossier strategy and relevant submission intelligence/approach, risks and solutions as relevant. 
  • Standardizing best practices for management of regulatory submissions to ensure consistency (e.g. defining submission process and timelines, adopting global core dossier and abbreviated dossiers concept and principles) 
  • Responsible for defining and governing processes related to eCTD readiness and authoring submission documentation (in close collaboration with Regulatory System and Data Management Dept) 

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