Global Regulatory Affairs Manager — Lead Submissions

AMGEN Capability Center Portugal in Lisbon seeks an experienced EU Regulatory Affairs Manager to ensure regulatory submissions and strategies across the EU region. You will support one or more products from an EU regulatory perspective within Amgen's Europe operations. The role involves collaboration with Global Regulatory Affairs teams, exposure to clinical...

Regulatory Affairs & Pharmacovigilance ManagerRegulatory Affairs & Pharmacovigilance ManagerWe are seeking aRegulatory Affairs & Pharmacovigilance Managerto lead our RA/PV team and ensure regulatory compliance and robust patient-safety systems across our clinical trials and client projects.Key ResponsibilitiesLead, develop, and support the RA/PV team,...

AMGEN Capability Center Portugal in Lisbon seeks an experienced EU Regulatory Affairs Manager to ensure regulatory submissions and strategies across the EU region. You will support one or more products from an EU regulatory perspective within Amgen’s Europe operations.The role involves collaboration with Global Regulatory Affairs teams, exposure to...

Viatris Inc. seeks a Regulatory Affairs Manager to lead and execute European regulatory strategies for a diverse portfolio of medicines, including generics and branded products.You will partner with Clinical, Quality, Legal, and Commercial teams to ensure compliant submissions and timely market access across EU member states. The role requires a university...

AMGEN Capability Center Portugal, located in Lisbon, seeks an EU Regulatory Affairs Manager to ensure EU licenses for trials and products. Join a diverse, innovative team shaping healthcare through regulation and strategy in Europe.The role involves planning regulatory submissions, guiding regional documents, and aligning with global strategies. Flexible...

Syneos Health is seeking a Senior Regulatory Project Manager to lead regulatory initiatives for a single Sponsor across international regions. The role focuses on end-to-end project management of regulatory submissions and lifecycle activities, collaborating with Global Regulatory Affairs and cross-functional teams. The ideal candidate brings 8+ years in...

Manage regulatory projects like COREP/Pillar 3 reporting and ESG requirements, coordinating implementation with Finance, RISK, IT, and COO teams.

IQVIA in Lisbon, Portugal, invites a Site Activation Manager to lead start-up activities across global programs, ensuring studies are activated efficiently, compliantly, and on schedule. You’ll work with sponsors, sites and cross-functional teams to accelerate enrollment and deliver high-quality trial outcomes.You will drive site feasibility, regulatory...