Regulatory Program Manager
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Hobson Prior are looking for a to Regulatory Program Manager join a leading pharmaceutical organisation who are dedicated to the well-being of patients all over the world. This role will be on a permanent basis and will be located in Beerse, Belgium.
- Translate the CDT/GRT strategy to functional plans with goals & objectives in alignment with therapeutic and program objectives.
- Provide context and history to new GRT members/partners. Utilize and embed GRA processes and tool to lead team and facilitate work.
- Provide outstanding global cross-functional operational leadership and management to drive risk management, prioritization, and decision-making-the RPM challenges the status quo and leads innovation.
- Coordinate GRT information, documentation, and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners (as the need arises).
- Steer GRT in a manner that fosters and maintains a high-performance team culture; As delegated, chair the GRT, Submission Working Group, Rapid Response Team meetings, and lead operations for regulatory, such as, management of Worldwide submissions, preparations for Health Authority meetings and other regulatory achievements.
- Submission Lead tasked with driving the project management of the submission team by setting direction, raising issues, establishing project management team R&R, developing detailed submission plans in appropriate planning tool.
- Work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
- Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan.
- Challenge innovation make it safe to try unique approaches and take prudent risks.
- Any other assigned duties.
- Over 5 years of proven experience in regulatory including at least 3-5 years in clinical development/(bio)pharmaceutical R&D.
- Experience in early strategic planning and cross functional management of global regulatory submissions and processes, both pre- and post-marketing (e.g. NDA, MAA, and lifecycle documents etc.) is required.
- Prior experience as a member of a cross-functional team is required.
- Demonstrated ability to resolve controversy and influence teams without formal authority is required.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.