Senior Submission Manager - 12 month
What you will have;
The Senior Submissions Manager will have a relevant Bsc with 7 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 Senior 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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