Global Regulatory Submissions Lead — Start-Up

Roche is seeking a Regulatory Submissions professional to lead dossier preparation for moderate‑complexity products and to craft global submission plans for market access. You will apply knowledge of IVDR, FDA, and ISO 13485 frameworks to ensure compliant pathways and collaborate with internal teams and external regulators. With 1+ years in Regulatory...

Novartis in Barcelona is seeking a Regulatory Team Lead, Maintenance and CTA, to guide a global regulatory team responsible for delivering high-quality clinical trial submissions and approvals. You will combine people leadership with regulatory expertise, building partnerships across the organization while driving smarter ways of working through...

Novartis Farmacéutica, S.A. is seeking a Regulatory Team Lead, Maintenance and CTA, to lead a global regulatory team delivering high-quality clinical trial submissions and approvals. Based primarily in Barcelona with hybrid working options, you will coach, allocate resources, and drive improvements across global Regulatory Affairs. You will shape the...

Novartis in Barcelona is seeking a Regulatory Team Lead, Maintenance and CTA, to guide a global regulatory team responsible for delivering high-quality clinical trial submissions and approvals. You will combine people leadership with regulatory expertise, building partnerships across the organization while driving smarter ways of working through...

A leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharmaceutical company in Barcelona. This role offers the opportunity to provide regulatory insight, author CMC documents, and coordinate activities for market expansion. The ideal candidate will have at least 5 years of experience in regulatory affairs,...

Premier Research is looking for a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we...

IQVIA Inc is seeking a Principal Medical Writer to develop regulatory documents for global submissions, including IBs, CSRs, and MA submission materials.You will guide cross-functional teams with minimal supervision to ensure scientifically rigorous, data-driven messages.You will lead and mentor medical writing projects across multiple compounds, ensuring...

IQVIA is seeking a Principal Medical Writer in Barcelona to lead the development of regulatory documents for global submissions (IBs, CSRs, and TARs). You will ensure data-driven messages are clear, accurate, and compliant with ICH guidelines and client standards, delivering high-quality manuscripts on schedule. You will mentor other writers, coordinate...

AstraZeneca plc in Barcelona, Spain seeks an experienced Regulatory Affairs Director to lead regional or global regulatory strategy. You will drive major health authority interactions, shape filing strategies, and coordinate NDA/IND submissions while guiding a cross-functional team to deliver on regulatory milestones. The role requires strategic...