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 Description
Role / ResponsibilitiesRegulatory Strategy & ComplianceDefine 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.
Ensure compliance with applicable regulatory requirements across assigned markets.
Lead registration projects and maintenance activities for marketing authorizations worldwide.
Monitor regulatory timelines,
risks and key deliverables across assigned projects.
Business Development & Strategic ProjectsParticipate in regulatory due diligence activities related to licensing, acquisitions and partnership opportunities.
Assess regulatory risks and opportunities associated with new products and portfolio expansion licensing-in and licensing-out projects from a regulatory perspective.
Provide regulatory input into strategic business decisions and innovation Collaboration & LeadershipAct 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.
Support the ongoing evolution of the Regulatory Affairs function and contribute to building future organizational capabilities.
The Successful ApplicantProfile / Experience8-15 years of experience within Regulatory Affairs in the pharmaceutical industry.
Exposure to licensing activities, regulatory due diligence, portfolio management and/or product
📌 Compliance Manager/Senior Manager (España)
🏢 Jobrapido
📍 España
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