Make your mark for patients
We are looking for a Global Submission Lead CMC & Devices to join us in our Regulatory Community Excellence & Operations team, based in our Brussels (Belgium) offices
About the role
The Global Submission Lead CMC & Devices initiates and drives both the strategic planning, coordination and the execution of GRA CMC & Devices submissions. This role requires effective collaboration and involves driving the GRA CMC & Devices team to align with the submission plan, ensuring adherence to agreed timelines.
Who you’ll work with
You will report into the Global Submission Team Lead
What you’ll do
1. Initiate and lead the development of GRA CMC & Devices strategic submission plan.
2. Ensure adherence to the submission plan, identifying problems, forecasting risks, and proactively seeking resolutions.
3. Manage priorities effectively.
4. Manage project tools, e.g. Integrate, Office Timeline Pro, SharePoint, as required by the project.
5. Partner with sponsors, stakeholders and teams from GRA CMC & Devices and Patient Supply by building and maintaining strong relationship.
Interested? For this position you’ll need the following education, experience and skills:
6. Bachelor’s degree
7. Several years of experience from either a cross functional role or from a line function in the pharmaceutical industry, CRO or comparable organization for drug development
8. Knowledge of regulatory processes (CTD), in particular CMC & Devices
9. Project Management techniques & people management in projects
10. Skilled in communication, leadership and influencing across the organization
11. Excellent self-management, priority setting and planning skills
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!