Global Regulatory Submissions

IQVIA Inc is seeking a Principal Medical Writer to develop regulatory documents for global submissions, including IBs, CSRs, and MA submission materials.¿Es este el siguiente paso en su carrera? Descubra si es el candidato adecuado leyendo la descripción completa a continuación.You will guide cross-functional teams with minimal supervision to ensure...

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 ***** frameworks to ensure compliant pathways and collaborate with internal teams and external regulators. With 1+ years in Regulatory...

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,...

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...

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...

Premier Research Group is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead and execute regulatory strategy, submissions, and approvals across multiple regions, coordinating CTAs, imports/exports, and complex regulatory packages for multi-region studies.You will act as the primary...

Job OverviewIndividual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials...

Novartis AG in Barcelona, Spain, seeks a Regulatory Manager, Maintenance and CTA, to lead regulatory submissions for clinical trial applications across an assigned portfolio, coordinating with study teams, country leads and cross-functional partners. The role requires a science degree with 4+ years of regulatory experience, plus strong planning,...