OverviewIn this role, you shape Regulatory Affairs strategy for a growing pharma portfolio across Rx and OTC.
You will lead regulatory planning, registrations, and lifecycle management in international markets, while driving cross-functional collaboration with R&D;, Quality, and Commercial teams.
You'll anticipate regulatory changes, manage timelines, and contribute to strategic business initiatives and licensing activities.
This is a transformation-driven role with broad exposure to integral scaling and portfolio expansion.
ResponsabilidadesDefine and execute regulatory strategies for products in development and on the market across international markets
Lead 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 for development, lifecycle, 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 to execute regulatory plans
Monitor timelines, risks, and deliverables across projects
Participate in regulatory due diligence for licensing,



acquisitions and partnerships
Provide regulatory input into strategic business decisions and innovation initiatives
Lead cross-functional projects with R&D;, Quality, Medical Affairs, Operations, Supply Chain and Commercial
Drive continuous improvement of regulatory processes and organizational capability
Requisitos principales8-15 years of experience in Regulatory Affairs within the pharmaceutical industry
Solid experience in international registrations and lifecycle management
Proven track record in developing and implementing regulatory strategies for products in development and on the market
Experience coordinating activities across international markets with external partners and distributors
Exposure to licensing, regulatory due diligence, portfolio management or product transfer projects (desirable)
Experience in corporate or headquarters environments valued
Strong stakeholder management and influencing capabilities
Strategic mindset with hands-on, adaptable approach in dynamic environments
Fluent English
Stakeholder management
Influencing and negotiation
Cross-functional collaboration
Regulatory strategy development
International registrations and lifecycle management
Regulatory due diligence

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