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)
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.