Do you have a solid regulatory background and project management skills and experience? Looking forward to an exciting mission at a global pharma company ? This opportunity may be what you are looking for.
Our client is looking to hire an Associate Director, Regulatory Program Manager. This role requires somebody who can offer a solid regulatory background on the one hand coupled with project management skills and experience on the other.
The Regulatory Program Manager (RPM) functions as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts. The RPM is accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. This individual provides operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed.
- Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.
- Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings and additional major regulatory milestones.
- Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration.
- Submission Leader tasked with driving project management of the submission team by setting direction, raising issues, establishing team R&Rs, developing detailed submission plans, and maintaining a close eye on critical path and associated analytics.
- Support GRT in a manner that fosters and maintains a high-performance team culture, chairing GRT, Submission Working Group, Rapid Response Team meetings, and similar, as required.
- Ensure coordination of critical GRT information 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 required.
- Provide global, cross-functional, operational leadership and management to drive risk management, prioritization, and decision-making, challenging the status quo and driving innovation.
- Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments.
- Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
- A minimum of a Bachelor's degree is required.
- Regulatory certification (RAC) is preferred.
- A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector.
- Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents)
- Leadership and management of global submission teams in a matrixed setting, with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan.
- Demonstrated experience conducting business process, scenario, and critical path analysis.
- Demonstrated understanding of Global Regulatory Affairs processes
- Knowledge of global regulations, guidelines and regulatory requirements
- Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred).
- Demonstrated ability to resolve controversy and influence teams without formal authority
- Proficient in written and spoken English
- Minimal local travel between sites
- Ability to work virtually
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17807