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About the role
- Medical & Regulatory Affairs Director leading medical, regulatory, quality strategies for Lundbeck products. Influencing global strategy and ensuring alignment with local activities across Spain and Portugal.
Responsibilities
- Define and lead the medical, regulatory, quality and pharmacovigilance vision, strategy, goals and activities to secure optimal support for Lundbeck products in Spain and Portugal
- Influence global Medical & Regulatory strategy and deliverables where regional and local needs must be reflected
- Ensure that regional and local scientific/medical activities are aligned with brand strategies and the existing product portfolio
- Play a strategic partner role together with Global teams by contributing and delivering Key insights to develop studies in phase 2 and 3
- 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
- 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
- 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
- Act as the affiliate representative for hosted Development staff and as a key contact to corporate QA functions
Requirements
- Experience leading medical, regulatory, pharmacovigilance and/or clinical development activities in an affiliate or cluster setting
- Strong track record of working in a cross-functional matrix, aligning multiple stakeholders and translating strategy into clear goals, plans and deliverables
- Experience engaging and influencing 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 events, advisory boards, medical information, promotional material review and medical training
- Experience overseeing or working closely with pharmacovigilance, including evaluation, documentation and reporting of adverse drug reactions and support to commercial teams, and managing or closely collaborating with regulatory affairs on submissions, interactions with health authorities, regulatory intelligence and compliance
- Proven people leadership experience, including building teams, developing talent, setting goals and conducting performance reviews
Benefits
- Inspiring workplace
- Innovative culture
- Development opportunities
- Initiatives focused on well-being
- Diverse workforce
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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