Experteer Overview
In this Regulatory Affairs role, you will shape regulatory strategies for products in development and in market, across international markets. You’ll lead registrations, variations, renewals and lifecycle management, ensuring compliance and anticipating regulatory changes. You will collaborate with Ru0026amp;D, Quality, Medical Affairs and commercial teams to drive portfolio initiatives and international launches. The position sits at the intersection of strategy and execution, offering broad exposure to Rx and OTC products and multiple markets. You’ll help evolve the Regulatory Affairs function through cross-functional leadership and process improvement.

Compensaciones / Incentivos
• Define and execute regulatory strategies for products across international markets
• Lead planning and execution of regulatory activities including registrations, variations, renewals and lifecycle management
• Assess impact of evolving regulatory requirements on the portfolio and ensure compliance
• Contribute to regulatory decision-making related to development, lifecycle management and portfolio initiatives
• Coordinate regulatory activities across multiple international markets and lead registration projects
• Support international product launches, market expansions and product transfers




• Collaborate with distributors, partners and external consultants for regulatory plans
• Monitor timelines, risks and deliverables across projects
• Participate in regulatory due diligence for licensing, acquisitions and partnerships
• Provide regulatory input to strategic business decisions and innovation initiatives
• Act as regulatory partner to Ru0026D, Quality, Medical Affairs, Operations, Supply Chain and Commercial teams
• Drive continuous improvement to regulatory processes and support evolving regulatory capabilities

Responsabilidades
• 8–15 years in Regulatory Affairs in pharma
• Experience managing international registrations and lifecycle management
• Proven track record in regulatory strategies for products in development and / or marketed
• Experience coordinating activities across international markets with external partners
• Exposure to licensing, regulatory due diligence, portfolio management and/or product transfers (desirable)
• Experience in corporate/headquarters environments valued
• Strong stakeholder management and influencing capabilities
• Strategic mindset with hands-on execution
• Fluent English

Requisitos principales
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📌 Regulatory Affairs Senior Manager (Barcelona)
🏢 Page Executive
📍 Barcelona