ppbAre you ready to leverage your global regulatory expertise to drive cross‑functional success and make a real impact across diverse international markets? Do you thrive in multicultural settings and have a natural ability to collaborate seamlessly across borders? If you're ready for a high‑visibility role guiding regulatory strategies across multiple regions, this could be your next career challenge at ALK. /b /p h3Position /h3 pAs bSenior Regulatory Affairs (RA) Manager /b, you will be the key RA in contact with the Head of International Markets and global stakeholders. Your mission: together with Integral Regulatory Leads to develop and drive integrated regulatory strategies and plans that support the timely development, registration, lifecycle management, and commercialization of ALK’s pharmaceutical products in the International Markets region. /p pYou will work in close partnership with Clinical Development, CMC, Supply Chain, Quality, Commercial, and regional teams—ensuring all regulatory activities, milestones, and submissions aligned with our global business objectives. /p pYour primary tasks will be to: /p ul liCollaborate with Global Regulatory Leads to translate regulatory strategies into actionable project plans and timelines. /li liIdentify critical regulatory milestones, dependencies, risks, and opportunities that may impact development programs and product registrations. /li liFacilitate cross‑functional planning meetings and ensure alignment of regulatory deliverables and timelines. /li liLead planning and tracking of global regulatory submissions,



including new marketing applications, variations, renewals, line extensions, and post‑approval changes. /li liEnsure submission schedules are realistic, resource‑aligned, and communicated effectively to stakeholders. /li liMonitor submission readiness and proactively address risks that could impact timelines. /li liMaintain visibility of regulatory activities and develop contingency plans to address potential delays or regulatory challenges within IM. /li liEnsure alignment between regulatory plans and commercial launch objectives. /li liIdentify, assess, and communicate regulatory planning risks and mitigation strategies. /li liPrepare regulatory planning metrics, dashboards, and status reports for leadership and governance forums. /li liGuide regulatory communication between external commercial partners and ALK Global Regulatory Affairs. /li /ul pThis is a truly international role, reporting directly to the Head of Global RA, Safety Pharmacovigilance, and working closely with the Head of International Markets. The position is not remote but the job location is flexible. You can be based in one of our European offices, with some international travel expected.



/p h3Your profile /h3 pWe expect that you have: /p ul liA bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline (master’s degree preferred). /li li5+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Project Management, or Regulatory Planning within the pharmaceutical industry. /li liExtensive knowledge of global pharmaceutical regulatory processes and requirements, including FDA, EMA, ICH, and other major health authorities. /li liDemonstrated experience managing international regulatory programs and submissions. /li liExperience from commercial interaction is an advantage as well as experience working within a global matrix organization and across multiple geographic regions. /li /ul pYour personal attributes: /p ul liDeveloped stakeholder management skills and the ability to influence without direct authority. /li liProactive, self‑motivated, and results driven. /li liDriven by working in multicultural settings with an instinctive ability to connect and collaborate across general teams. /li liHighly organized and detail‑oriented while being resilient in a fast‑paced, changing environment. /li liStrong problem‑solving and decision‑making capabilities. /li liCommitment to quality, compliance, and continuous improvement. /li liWillingness to travel 20‑30 days per year. /li /ul h3Equal Opportunity /h3 pWe commit to an inclusive recruitment process and equal opportunity for all our job applicants. /p /p #J-18808-Ljbffr

📌 Senior Regulatory Affairs Manager - International Markets (España)
🏢 ALK
📍 España