Description
We have a new opportunity for Regulatory Affairs Project Manger CMC to support submission process and improvement for all new and existing global projects.The position can be based in Brussels and in the UK and the company offers support in relocation, excellent remuneration package and benefits.
Responsibilities:
* Collaborate on the development of strategic plan for the project with focus on CMC and collaboration with the technical organization
* Ensure operational initiatives aiming at rapidly piloting, developing and establishing efficient paths to market for new solutions.
* Stakeholder management with relevant interfaces in and outside of the organization, including management of external partners as needed
* Scenario planning for the asset/project - ensuring flexible and agile use of resources and funding.
* Plan, track and monitor project progress across all Submission aspects, identifying problems, forecasting risks, and proactively seeking resolutions.
* Track and monitor performance of the team/project against annual and long-term objectives (resourcing, information gathering, data analysis, draw conclusions and status reporting).
* Train others in the team on project management concepts and processes as appropriate. Ensure onboarding of team members.
* Manage project tools, e.g. Integrate, SAP, SharePoint, Integrated Project Plan as required by the project.
* Create communications for internal and external stakeholders (content perspective) incl. information gathering, making sure strategic concepts are in alignment.
Experience required:
* Scientific degree
* Solid experience gained in the pharmaceutical industry in CMC area
* Prior experience in project management and successful submission process management
* Working knowledge of the Common Technical Document (in particular module 3), drug development processes and Regulatory Filing Procedures
* Commercial/business acumen
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.