Medical and Regulatory Affairs DirectorAre you motivated by shaping medical, regulatory, quality, pharmacovigilance and clinical strategies that impact patients across countries? In this leadership role, you will drive the Medical and Regulatory Affairs agenda for Spain and Portugal, working cross:functionally and externally with key stakeholders to secure optimal support for Lundbeck's products throughout their lifecycle.Your new roleIn this role, you are accountable for defining and leading the medical, regulatory, quality and pharmacovigilance vision, strategy, goals and activities to secure optimal support for Lundbeck products in Spain and Portugal.Stylemargin:bottom:0.0in;
Margin:top:0.0px::You will serve as a key member of the leadership team, contributing to overall business strategy and decision:making.:You will set and execute the medical strategy for neuro:rare ensuring alignment with global and local goals.:You will influence global Medical and Regulatory strategy and deliverables where regional and local needs must be reflected and ensure that regional and local scientific/medical activities are aligned with brand strategies and the existing product portfolio.:You will play an strategic partner role together with Global teams by contributing and delivering Key insights to develop studies in phase 2 and 3.:You will lead Medical Advisors and Medical Science Liaisons, providing strategic direction and overseeing medical affairs activities, including scientific communication, KOL engagement, CME programmes, advisory boards and medical input to access strategies and HTA dossiers.:You will interact with scientific societies and guideline groups, regional and local competent authorities and other external stakeholders to support the best possible development, market access and on:market position of Lundbeck products.:You will also oversee local pharmacovigilance, clinical development and regulatory affairs activities, ensuring that safety reporting, clinical trial support and regulatory submissions are managed in line with regulations, internal standards and inspection:readiness expectations.:You act as the affiliate representative for hosted Development staff and as a key contact to corporate QA functions.Your future teamYou will be an active member of the affiliate management team and lead a multidisciplinary R and D organisation across Spain and Portugal. Your remit covers Medical Affairs, Pharmacovigilance, Regulatory Affairs and Clinical Development support, including Medical Advisors, MSLs and local RA/PV staff.Working in a cross:functional matrix and across country borders, you will collaborate closely with colleagues in commercial, market access, QA and corporate R and D to align priorities and secure the resources and commitment needed to deliver on the local and regional R and D agenda.You will foster a culture of compliance, continuous improvement and knowledge sharing, including the development and maintenance of local medical SOPs and cluster HCP reporting practices in line with applicable requirements.What you bring to the teamYou are an experienced R and D leader who enjoys combining scientific depth with strategic thinking, operational excellence and people leadership.You bring:stylemargin:bottom:0.0in;
Margin:top:0.0px::Experience leading medical, regulatory, pharmacovigilance and/or clinical development activities in an affiliate or cluster setting.:Experience in Rare Diseases.:A strong track record of working in a cross:functional matrix, aligning multiple stakeholders and translating strategy into clear goals, plans and deliverables.:Experience engaging external stakeholders such as KOLs, scientific societies, guideline committees, health authorities and other competent bodies.:Experience overseeing or contributing to medical affairs activities, including KOL management, scientific