This role coordinates and drives the Business Strategy for EUCAN Marketing Company Regulatory Affairs (EUCAN MCRA) including the digital agenda, simplification, and improvement projects in close collaboration with the Executive Director EUCAN, Senior Regional Director EU and EUCAN Marketing Company Regulatory Affairs (MCRA) Heads and all relevant Global Functions.
Internal Focus Leads and/or drives the EUCAN MCRA digital agenda, driving the digital transformation in the MCRA EUCAN. In this role, he/she is member of the Global Regulatory Digital Strategy Team representing EUCAN MCRA. Leads and/or drives EUCAN MCRA simplification and improvement projects. Leads and/or drives EUCAN MCRA knowledge sharing initiatives. Leads EUCAN MCRA specific non-product related projects. Leads partnership with Alexion in EUCAN markets. Identifies regulatory non-product related system and project challenges and develops solutions in close collaboration with relevant internal stakeholders. Works with EUCAN MCRA Heads and Global Functions to agree and deliver the overall EUCAN digital and simplification agenda including innovative solutions. Engagement with and leads interactions with external vendors as required. Partners and collaborates effectively with key internal stakeholders such as global regulatory, other relevant R&D functions and operations and relevant EUCAN MC staff. Ensures best practice is shared across regulatory functions. Sets high standards and objectives according to AZ values and procedures. External Participate in relevant trade association/industry working groups to influence policy/rulemaking in alignment with business strategies and company positions. Share industry best practices and insights. Education, Qualifications, Skills and Experience Essential 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. Digital mindset Experienced change manager Agile working style 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 managing people in a matrixed organizational structure. Ability to think strategically and critically. Strategic influencer of key stakeholders/leaders), innovative, taking initiative, and strong leadership. Excellent collaboration, team working, oral and written communication skills. Willingness to undertake domestic/international travel. Desirable Advanced degree in a scientific discipline (e.g. MSc, PhD, PharmD, MD)
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