- Opportunity to play a key role in shaping the future of Regulatory Affairs.- Company undergoing a significant transformationAbout Our ClientOur client is a well-established pharmaceutical company with an international footprint and a growing focus on innovation, portfolio expansion and general development. The company is investing in new capabilities, strengthening its international presence and enhancing cross-functional collaboration to support the next stage of its growth.The company manages an extensive portfolio across both prescription (Rx) and over-the-counter (OTC)Job DescriptionRole / 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.The Successful ApplicantProfile / Experience- 8-15 years of experience within Regulatory Affairs in the pharmaceutical industry.- Solid experience managing international registrations and lifecycle management activities.- Proven track record developing and implementing regulatory strategies for products in development and commercialized products.- Experience working across international markets and coordinating activities with external partners and distributors.- Exposure to licensing activities, regulatory due diligence, portfolio management and/or product transfer projects is highly desirable.- Experience within corporate or headquarters environments will be particularly valued.- Strong stakeholder management and influencing capabilities.- Strategic mindset combined with a hands-on approach.- Ability to thrive in dynamic and evolving environments.- Fluent English.What’s on Offer- Opportunity to join a company undergoing a significant transformation and international growth journey.- Exposure to a broad and diverse portfolio across both Rx and OTC products, marketed in more than 50 international territories.- A highly visible role with significant interaction across R&D, Medical Affairs, Quality, Commercial and senior leadership teams.- Participation in international projects, portfolio expansion initiatives and strategic business activities.- The opportunity to make a tangible impact on the future evolution of the Regulatory Affairs function.- A dynamic environment that encourages collaboration, innovation and professional growth.#J-18808-Ljbffr

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