Role / ResponsibilitiesRegulatory Strategy & Compliance

- Define and execute regulatory strategies for products under development and commercialized products across international markets.
- Lead the planning and execution of regulatory activities including new registrations, variations, renewals and lifecycle management.
- Assess and anticipate the impact of evolving regulatory requirements on the company's portfolio.
- Ensure compliance with applicable regulatory requirements across assigned markets.
- Contribute to regulatory decision-making related to product development, lifecycle management and portfolio initiatives.

Portfolio Management & International Regulatory Activities

- Coordinate regulatory activities across multiple international markets.
- Lead registration projects and maintenance activities for marketing authorizations worldwide.
- Support international product launches, market expansions and product transfer initiatives.
- Collaborate with distributors, partners and external consultants to ensure successful execution of regulatory plans.
- Monitor regulatory timelines,



risks and key deliverables across assigned projects.

Business Development & Strategic Projects

- Participate in regulatory due diligence activities related to licensing, acquisitions and partnership opportunities.
- Assess regulatory risks and opportunities associated with new products and portfolio expansion initiatives.
- Support licensing-in and licensing-out projects from a regulatory perspective.
- Provide regulatory input into strategic business decisions and innovation initiatives.

Cross-Functional Collaboration & Leadership

- Act as a trusted regulatory partner to R&D;, Quality, Medical Affairs, Operations, Supply Chain and Commercial teams.
- Lead and contribute to cross-functional projects involving multiple stakeholders.
- Drive continuous improvement initiatives aimed at enhancing regulatory processes and efficiency.
- Support the ongoing evolution of the Regulatory Affairs function and contribute to building future organizational capabilities.

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