
Regulatory Affairs Customer Success Manager
- Zaragoza
- Permanente
- Tiempo completo
- Overall accountability for assigned complexity 2 customer engagements;
- Responsible and accountable for assigned project to ensure it is within expected costs, resources, timelines and budget and meets expected quality standards;
- Responsible to determine project scope and objectives, oversee project plans and monitor progress;
- Responsible to predict resources needed to reach project objectives, establish clear roles and define output they need to deliver;
- Responsible for implementing governance structure with defined roles and responsibilities and escalation pathways
- Identifies and proactively manages risks and leads mitigation measures
- Ensures effective and transparent communication and working relationships with Client and project (workstream) team members;
- Manage change with the team when necessary to meet project deliverables;
- Accountable that all project team are onboarded, trained accordingly and aware of their responsibilities within the engagement;
- Provide Regulatory insights and experience as relevant to the assigned project;
- Act as an ambassador for project management excellence.
- Bachelor’s degree in a relevant discipline and/or PMP certification, or equivalent experience.
- Proven experience in complex project management
- Several years’ experience and profound knowledge and expertise in Regulatory Affairs enabling technical understanding for the assigned project.
- Familiarity with global industry principles of Regulatory Affairs
- Experience in a range of operational tasks that are performed by the members of the Regulatory department
- Familiarity with regulatory requirements (FDA, EU-GVP, ICH)
- Understanding the Regulatory background of the contracted deliverables
- Extensive experience and proven strength in leading, mentoring, managing and motivation of staff
- Ability to lead large international and/or complex project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones; convincing others in difficult change management situations
- Ability to manage client relationships at all levels including C-suite, ability to convey strategic goals of collaboration
- Excellent communication and negotiation skills (written and verbally), proven capability to communicate critical issues and proposed solutions to senior management levels; ability to convey stakeholders even in critical or sensitive situations. Excellent skills in presentation
- English business fluent