Global Regulatory Project Manager
1 day ago
RBW Consulting is seeking a Global Regulatory Project Manager - CMC to lead our team's efforts in managing CMC regulatory activities for clinical programs. This role involves overseeing change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews.
Main Responsibilities:- Lead CMC regulatory activities for clinical programs, including authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release documents.
- Collaborate with external CMOs and manage post-submission activities.
- Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products.
- Pre- and post-approval CMC regulatory activities experience.
- Effective stakeholder management, project management within a CMC context.
- Knowledge of IND/NDA and IMPD/MAA formats, understanding of drug substance and product CMC.
- Organized, independent, and able to manage multiple activities.
- Degree in Pharmacy or a relevant science/technical subject, proficient in English, French is an advantage.
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Global Oncology Regulatory Specialist
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CMC Regulatory Project Manager
3 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeAs a seasoned CMC Regulatory Project Manager at RBW Consulting, you will oversee regulatory activities for small molecule oncology products globally. This contract position involves managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and...
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CMC Regulatory Project Lead
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Senior Regulatory CMC Manager
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CMC Regulatory Specialist
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Geobear Global Territory Manager
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CMC Regulatory Lead
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HV Cable Project Manager and Engineer
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Engineering Design Project Manager
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Door Installation Project Manager
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Global Project Coordination Specialist
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