Senior Regulatory Affairs Manager
2 weeks ago
Senior Regulatory Affairs Manager CMC
A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector) experience.
for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications
with internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections
the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g. in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry
knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations
interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable
PhD or Masters) preferred.
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer
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Senior Regulatory Affairs Manager CMC
2 days ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob Description Job title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device...
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Cambridge, Cambridgeshire, United Kingdom Hays Full timeJoin this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will...
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Cambridge, Cambridgeshire, United Kingdom Hays Full timeJoin this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will...
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Regulatory Affairs Manager
7 days ago
Cambridge, Cambridgeshire, United Kingdom Hays Full timeYour New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract...
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Regulatory Affairs Manager
3 days ago
Cambridge, Cambridgeshire, United Kingdom Hays Full timeYour New Company: Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. Your New Role I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract...
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Senior Manager Regulatory Affairs Writing
2 days ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob Description Job title: Senior Manager Regulatory Affairs Writing A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. The role will play a pivotal role in the clinical development team. You will lead a team responsible for developing the content for submissions to both US and EU...
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Senior Manager Regulatory Affairs Writing
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Manager Regulatory Affairs Writing A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. The role will play a pivotal role in the clinical development team. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies. ...
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Senior Manager Regulatory Affairs Writing
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Manager Regulatory Affairs Writing A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. The role will play a pivotal role in the clinical development team. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies. ...
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Cambridge, Cambridgeshire, United Kingdom Hays Full timeJoin this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment. I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client.
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Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeSenior Manager Regulatory Affairs Vendor Governance page is loaded Senior Manager Regulatory Affairs Vendor Governance Apply locations United Kingdom - Cambridge time type Full time posted on Posted 6 Days Ago job requisition id R0040568 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...
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Senior Regulatory Affairs Manager CMC
2 hours ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMCRemember to check your CV before applying Also, ensure you read through all the requirements related to this role.A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...
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Senior Regulatory Affairs Manager CMC
2 weeks ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto...
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Senior Regulatory Affairs Manager CMC
1 week ago
Cambridge, United Kingdom Pharma Partners Recruitment Ltd Full timeJob DescriptionJob title: Senior Regulatory Affairs Manager CMCA growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical...
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Senior Manager, Regulatory Compliance
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full timeSenior Manager Regulatory Affairs Writing A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Manager Regulatory Affairs Writing. You will lead a team responsible for developing the content for submissions to both US and EU regulatory agencies. scientific contribution to the development of medical, regulatory and clinical...
