Global Regulatory Submissions Lead — Start-Up

IQVIA Inc is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions.You will guide cross-functional teams to ensure high-quality, data-driven documents (IBs, CSRs, submission dossiers) meet regulatory standards and program goals.You will oversee timelines, mentor other writers, and contribute to SOPs and...

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex.The company's customer-centric flexible service model, innovative technology, expert team members, and global...

OverviewAs Regulatory Submissions Lead II, you steer global regulatory strategy and submissions across studies to secure approvals for novel therapies and devices.You'll partner with cross-functional teams to manage CTAs, regulatory documents, and start-up activities, ensuring alignment with timelines and country requirements.You'll own submission quality...

Diagnostic Quality & Regulatory Affairs Operations SpecialistWe believe that diversity adds value to our business, our teams, and our culture.We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.¿No sabe con seguridad qué habilidades necesitará para esta oportunidad?Simplemente lea la...

Expert - Information Security & Privacy Governance At Roche you can show up as yourself, embraced for the unique qualities you bring.Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.This is how we aim to...

Remote Technical Services Specialist Surgical RoboticsMadrid MedtronicRemoteHeerlen, Limburg, NetherlandsMadrid, Madrid, SpainMilano, Lombardia, ItalyLisboa, Lisboa, PortugalFull timeR*****Careers that change lives start here.Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.Our 95,000...

Coinspaid Solutions is a fintech company building blockchain payment infrastructure for the global economy.We design, implement, and scale payment systems that connect digital assets with real-world financial operations.Our solutions help businesses and financial institutions operate efficiently in the evolving digital asset landscape.For over 11 years,...

OverviewAs Startup Specialist, you drive the start-up of clinical trials across multiple sites, ensuring regulatory compliance and quality.You work with cross-functional teams and the Regional Submission Lead to hit milestones and tailor study documents to country needs.You oversee document management, submissions, and amendments, while maintaining...

OverviewAs Director, Study Start Up-EU you lead the SSU group across the region, aligning strategy with project delivery and client expectations.You'll partner with PM, Clinical Leadership and Business Development to ensure smooth regulatory submissions, site activation and contract alignment.You drive operational excellence, manage risk, and develop staff...