Overview In 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 general scaling and portfolio expansion.

Responsabilidades

- Define 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 principales
- 8-15 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