• Job Description

  Req#: R-177603

  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 10 years of regulatory affairs experience
  • Experience in global regulatory strategy and submissions that have progressed through to registration
  • Must have significant experience in leading major health Authority interactions
  • Ability to work closely with Country Commercial Organization and interact with Regional Leadership and Country Leadership
  • Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority, as well as experience to interact with Region’s Officials (e.g., European Commission, European Parliament)
  • Experience in leading people in a matrixed organizational structure.
  • Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities for the Region with effective judgement and decision-making in sophisticated business critical situations.
  • Strategic influencer of key partners/leaders), innovative, taking initiative, and strong leadership.
  • Excellent collaboration, team working, oral and written communication skills.
  • Willingness to undertake domestic/international travel.

  Desired Qualifications:

  • Advanced degree in a scientific field (e.g. MSc, PhD, PharmD, MD)

  Why AstraZeneca?

  At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

  So, what’s next!

  Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

  Date Posted

  18-ago-2023

  Closing Date

  17-sept-2023

  AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• About the company

  AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.

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