Medical & Regulatory Affairs Director

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Are 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 & 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 role
In 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.

Key member of the leadership team, contributing to overall business strategy and decision-making.

Set and execute the medical strategy for neuro-rare ensuring alignment with global and local goals.

Influence global Medical & 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.

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.

Your future team
You will be an active member of the affiliate management team and lead a multidisciplinary R&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&D to align priorities and secure the resources and commitment needed to deliver on the local and regional R&D agenda.

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 Team
Experience leading medical, regulatory, pharmacovigilance and / or clinical development activities in an affiliate or cluster setting.

Experience in Rare Diseases.
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 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.

Collaborate effectively, keep a strong customer and results focus, adapt to…