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Pharma Partners Recruitment Ltd
Cambridge, England, United Kingdom
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 medical de
Job Source: Pharma Partners Recruitment LtdHays
GB
Your 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 contra
Job Source: HaysHays Specialist Recruitment Limited
United Kingdom
Your 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 contrac
Job Source: Hays Specialist Recruitment LimitedPharma Partners Recruitment Ltd
Cambridge
Job DescriptionJob title: Senior Manager Regulatory Affairs WritingA 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 regu
Job Source: Pharma Partners Recruitment LtdPharma Partners Recruitment Ltd
Cambridge, England, United Kingdom
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 regulatory agenc
Job Source: Pharma Partners Recruitment LtdOmega Diagnostics Ltd
Ely, Cambridgeshire
Regulatory Affairs Supervisor Location: Littleport, Cambridgeshire - CB6 1SE Salary: £45k + Benefits Contract: Full time, Permanent Hours: 37.5 pw Benefits: 25 days holiday a year plus bank holidays, increases with length of service Company pension scheme, minimum 4% contribution Private healthcare after successful completion of the probationar
Job Source: Omega Diagnostics LtdPlanet Pharma
cambridgeshire, england, United Kingdom
LOCATION : Cambridge PROJECT LENGTH : 12 month contract FTC SUMMARY : I am working with a very exciting pharmaceutical company for a brand new role within Protein Sciences. It is a 12 month contract hybrid in Cambridge (2 days a week on site). They are looking for a talented professional to join the Protein sciences team and work as part of a cr
Job Source: Planet PharmaPlanet Pharma
Cambridgeshire
Job Description LOCATION : Cambridge PROJECT LENGTH : 12 month contract FTC SUMMARY : I am working with a very exciting pharmaceutical company for a brand new role within Protein Sciences. It is a 12 month contract hybrid in Cambridge (2 days a week on site). They are looking for a talented professional to join the Protein sciences team and
Job Source: Planet PharmaCambridge
Job 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 device (auto injector) experience.Responsibilities:for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applicationswith 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 inspectionsthe preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g. Module 3 IND, IMPD, amendments and annual reportsRequirements:in CMC Regulatory Affairs within the pharmaceutical or biotechnology industryand knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is requiredknowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulationsworking with recombinant proteins is highly desirableinteractions with health authorities such as scientific advice or agency meetings, including with FDA, is desirableof first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.Salary and benefits:A highly competitive salary, stock options, annual bonus and wider benefits package is on offerTo apply for this position or hear further details then please contact Matt Thomas via [email protected]
Senior Regulatory Affairs Manager CMC jobs in Cambridge
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