Executive Director Eucan Regulatory Affairs

hace 2 semanas

Barcelona, España AstraZeneca A tiempo completo

The Executive Director EUCAN provides global strategic regulatory expertise and oversight to support the EUCAN countries and integrate the EUCAN countries into the global Regulatory Affairs network of AstraZeneca. The Executive Director EUCAN organizes the relevant Marketing Companies (MC) network and ensure their regulatory organizations are included in the execution strategy for portfolio products during product life cycle (e.g., Clinical Trial Applications, Marketing Applications, Variations to Marketing Applications, etc.), are connected to AstraZeneca systems and processes, and are integral members of the MC leadership teams. This position reports to the SVP ORSSE and covers the entire AstraZeneca portfolio of products.

The Executive Director possesses strategic leadership skills, has a deep understanding of regulatory affairs, particularly for the region concerned, and a deep understanding of the development processes and strategies for high profile, complex or novel development programs to influence cross functional discussions with relevant senior internal and external collaborators. The ability to function in multiple capacities to deliver the overarching strategy for the region is a requirement for this role.
- Partner with and mentors the MC regulatory leaders in the Region to align on portfolio-related global regulatory strategies and their execution at MC level in coordination with the global plans approved by LSPC for the therapeutic areas concerned.
- Coordinate the Region network of regulatory leaders to ensure effective execution of the regulatory strategies.
- Ensure alignment on timelines relating all types of submissions.
- Effectively represent the Region for regulatory activities and strategic goals in Regulatory Governance and Commercial Regional Governance, and any appropriate senior level interactions within AstraZeneca and externally. In this capacity, the Executive Director is the representative of AstraZeneca to the European Medicines Agency (EMA), is the industry Single Point of Contact (iSPOC) within the scope of crisis preparedness and management (e.g., COVID-19), as well as the signatory of the Plasma Master File (PMF), among other duties related to AstraZeneca’s necessary regulatory interface with the European Medicines Agency.
- Provides critical review and input for the Region on portfolio regulatory strategies, risk planning and mitigations in partnership with RADS, SRADS, and Regulatory Leadership.
- Organize the through the relevant MCs the regional policy and intelligence in collaboration with Central Policy functions to critically analyse, communicate, and advise Senior Regulatory Affairs leaders in the TAs and Shared Functions for implementation.
- When appropriate this position represents the reginal function at key global health authority meetings and with external partners (e.g., European Commission representatives, Trade Association representatives).
- Ability to optimally coordinate the regional regulatory network of MC Regulatory Leaders to have a meaningful strategy in place that supports global Development strategies and global implementation of system and processes, while ensuring compliance with local requirements.
- Lead the network members (dotted line) and direct reports to their full potential; providing coaching, mentoring, skill development and performance feedback.
- Ability to own the budget management, resource planning and recruitment of staff. Advises on the appropriate deployment of MC Regulatory Teams in line with AstraZeneca’s strategy, and regularly review such allocation to ensure optimum utilization and development of staff.
- Ability to drive succession planning.
- Proactively contributes to the AstraZeneca Regulatory Community and as such represent the Region on the Regulatory Management Board (RMB).
- Acts as a role model senior TA leader and implements the GRA vision.
- Lead complex non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory Affairs (GRA) when necessary.
- Responsible for reviewing and approving high-level documents for global regulatory submissions as well as core prescribing information.
- Accountable that submission excellence framework is timely and consistently applied across projects including sharing best submission practices and knowledge and using existing tools (toolbox).
- Provide effective strategic technical mentorship to selected x-functional submission teams from kick-off to submission delivery and defense work up till approval. This includes coaching on submission process, content and team leadership/dynamics. Conduct, collect and share “performance” and “health” metrics with x-functional submission teams.
- Ensure lessons learned/standard processes are collected and embedded in submission excellence framework.

**Minimum Qualification**:

- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
- More than 1

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