Remote CMC Regulatory Manager
4 semanas atrás
A biopharmaceutical solutions organization is seeking a Regulatory CMC Manager to support global regulatory CMC activities. This role involves preparing documentation, collaborating with cross-functional teams, and ensuring compliance through the marketing authorization stages. Candidates must have prior regulatory CMC experience and strong communication skills. This position is hybrid/remote in Portugal, offering full-time employment.
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Regulatory CMC Manager/Regulatory Consulting
4 semanas atrás
Lisboa, Portugal Syneos Health, Inc. Tempo inteiroRegulatory CMC Manager/Regulatory Consulting - hybrid/remote (Serbia, UK, Portugal) Updated: December 15, 2025 Location: Lisboa, 1, Portugal Description Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...
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Lisboa, Portugal Organon Tempo inteiro**The Position** Reporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful **Associate Principal Scientist**will be accountable for assessment of changes for regulatory impact, development of regional CMC strategy in EU/EEMEA, preparation of CMC documentation and execution of regional...
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Lisboa, Portugal Organon Tempo inteiro**The Position** Appointment to this position will be on local salary and benefits package. **Responsibilities**: The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following...
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Lisboa, Portugal サイネオス・ヘルス Tempo inteiro**Updated**: Today **Location**: Lisboa, 1, Portugal **Job ID**: 25103768-OTHLOC-3540-2DR - Not ready to apply? Join our Talent Network **Description** CMC - Regulatory CMC Consultant / Snr Consultant Cell and Gene Therapy (Serbia/Spain/UK/Portugal) )HybridSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to...
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Lisboa, Portugal Syneos - Clinical and Corporate - Prod Tempo inteiro**Description** CMC - Regulatory CMC Consultant / Snr Consultant Cell and Gene Therapy (Serbia/Spain/UK/Portugal) )Hybrid Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...
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Lisboa, Portugal Organon Tempo inteiro**The Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance...
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Lisboa, Portugal Organon Tempo inteiro**The Position** The Associate Director (Associate Principal Scientist), Organon, Manufacturing & Supply, Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support, for Organon Network projects. This position will lead the preparation, and submission of CMC dossiers for assigned Network Projects....
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Sr. Scientist, Regulatory Affairs
2 semanas atrás
Lisboa, Portugal Organon Tempo inteiro**The Position** **Responsibilities** - Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks. - Execute global regulatory strategies by leading the...
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Sr. Scientist, Regulatory Affairs
Há 6 dias
Lisboa, Portugal Organon Tempo inteiro**The Position** **Responsibilities** - Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks. - Execute global regulatory strategies by leading the...
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Lisboa, Portugal Grünenthal Tempo inteiroshare - mail - share - share Global Quality Product Manager External Supply **Country**:Portugal **City**:Lisbon **Department**:Global Operations & Production **Job ID**:44579 **Job Grade**: **Hiring Manager**: Joana Gaspar**Internal Posting Date**: 17/04/2025- Professional | Permanent | Full-time | Hybrid - Our people in **Manufacturing & Global...