Descripción de la oferta
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 global scaling and portfolio expansion.
ResponsabilidadesDefine and execute regulatory strategies for products in development and on the market across international marketsLead regulatory activities including registrations, variations, renewals and lifecycle managementAssess impact of evolving regulatory requirements on the portfolio and ensure complianceContribute to regulatory decision-making for development, lifecycle, and portfolio initiativesCoordinate regulatory activities across multiple international markets and lead registration projectsSupport international product launches, market expansions and product transfersCollaborate with distributors, partners and external consultants to execute regulatory plansMonitor timelines, risks, and deliverables across projectsParticipate in regulatory due diligence for licensing, acquisitions and partnershipsProvide regulatory input into strategic business decisions and innovation initiativesLead cross-functional projects with R&D, Quality, Medical Affairs, Operations, Supply Chain and CommercialDrive continuous improvement of regulatory processes and organizational capability
Requisitos principales8-15 years of experience in Regulatory Affairs within the pharmaceutical industrySolid experience in international registrations and lifecycle managementProven track record in developing and implementing regulatory strategies for products in development and on the marketExperience coordinating activities across international markets with external partners and distributorsExposure to licensing, regulatory due diligence, portfolio management or product transfer projects (desirable)Experience in corporate or headquarters environments valuedStrong stakeholder management and influencing capabilitiesStrategic mindset with hands-on, adaptable approach in dynamic environmentsFluent EnglishStakeholder managementInfluencing and negotiationCross-functional collaborationRegulatory strategy developmentInternational registrations and lifecycle managementRegulatory due diligence
