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- ...Engineering discipline and/or equivalent combination of work experience is required. 5+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred. Minimum of 2 years working within quality systems...SuggestedFor contractorsWork experience placementImmediate start
- ...equivalent combination of education and experience is required. Experience 2-3 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred. Hands-on experience with batch record review and product...SuggestedShift work
$40 - $44 per hour
...completing tasks, notifying manager of decisions outside established processes, and building an internal network. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required. Demonstrated experience with quality management systems...SuggestedHourly payContract workWork experience placement- ...and execution of deviation initiation, investigations, and approvals within a quality management system. Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Minimum of 4 years working within quality systems managing...SuggestedFor contractorsImmediate start
- ...labeling changes. Own health authority strategy and execution across both programs, from pre‑NDA meetings through Type B/C/D meetings and EMA Scientific Advice, including briefing packages, question strategy, and rehearsal. Anticipate regulatory risks, questions, and...Suggested
- ...and execution of deviation initiation, investigations, and approvals within a quality management system. Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Minimum of 4 years working within quality systems managing...Suggested
$226k - $270k
...regulatory submissions, health authority meetings and interactions with in-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities. Has a comprehensive and disciplined approach to regulatory risk management and compliance...SuggestedLocal areaFlexible hours- ...team through dynamic, cross-functional collaboration. You will drive regulatory submissions (INDs, BLAs, NDAs), interact with FDA and EMA, and stay ahead of industry changes to maximize global regulatory success in complex programs. This role is based in Bothell, WA. #J...Suggested
$175k - $199.58k
...resolution to ensure timely and effective trial execution. Quality Assurance and Regulatory Compliance Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for assigned trials . Work with Quality Assurance and the CST to support and ensure ongoing...Suggested$40 - $44 per hour
...for Document Control. This role entails managing GMP records and supporting document approval processes, ensuring compliance with FDA/EMA regulations. Candidates should possess strong communication skills and a background in records management in regulated environments....SuggestedHourly pay$150k - $200k
...(e.g. CRFs, Data Management Plan, SAPs, etc.) Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies Develop software systems to generate displays of clinical study data as tables, listings, and...SuggestedContract workWorldwide$90.66k - $109.86k
...Requirements ~ Bachelor's degree in science or engineering discipline or equivalent work experience ~5+ years cGMP experience; FDA/EMA biotech or cellular therapy experience preferred ~ Minimum 2 years managing deviation and CAPA records in quality systems ~...SuggestedWork experience placement$139.1k - $231.9k
...submission, inspection, and regulatory approval. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory...SuggestedPermanent employmentH1bWork at officeLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...training and cross-functional collaboration Requirements Deep experience with GCP, GLP, GVP, and global regulatory frameworks (FDA, EMA, ICH) Proven track record leading quality assurance in clinical drug development Strong expertise in Quality Management System...Suggested
$139.1k - $231.9k
...clinical trial experience, preferably on sponsor side with regulatory approval track record Deep knowledge of ICH guidelines, GCP, FDA, EMA, and global regulatory requirements Expertise in clinical operations, safety assessment, biostatistics, and regulatory disciplines...SuggestedWork at office$320k - $350k
...with direct small-molecule experience; recent small-molecule experience preferred. ~ Deep knowledge and practical application of FDA, EMA, ICH, GMP, GCP, and GVP requirements, including ICH Q9(R1) and ICH Q10 principles. ~ Demonstrated experience personally designing,...Contract workTemporary workImmediate startFlexible hoursLeonaBio, Inc.
Bothell, WA2 days ago$22 - $26 per hour
...environment and maintain a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR to document all pertinent elements of a patient exam accurately and thoroughly, and other duties as assigned. Our medical...Hourly payTemporary workWork experience placementWork at officeLocal area$70k - $85k
...Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP) Requirements BS + in pharmacology, toxicology, biology or chemistry, or related...Full timeRemote work$100 - $150 per hour
...Knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), and knowledge of cGCP, cGLP and cGMP. Knowledge of risk management, project reporting, and project management tools required. Strong...Hourly payContract workWork at officeLocal areaWorldwide- ...complete with specialized equipment and procedure rooms Strong patient volumes produced through local referring physician network EMA charting system About the Community: Nestled on the northeastern shores of Lake Washington, Kirkland blends small-town charm...Local areaImmediate startRelocation package
$199k - $256k
...interplay between patent strategy and regulatory exclusivities (NCE/data, orphan drug, patent term extension) across FDA, Health Canada, and EMA, and partner with investor relations on IP-related disclosure. Trade secrets, enforcement, and risk management Review and maintain...Contract workWork at officeLocal areaWorldwide$25 - $31 per hour
...spreadsheets/software) 2 months in advance. Compliance Monitoring, Service Recovery & Safety On a weekly basis, verify all the provider's EMA path and lab logs are correctly updated by the MAs and providers and communicate discrepancies to each clinical team as appropriate....Hourly payTraineeshipWork experience placementWork at officeLocal areaMonday to FridayShift work2 days per week- ...complete with specialized equipment and procedure rooms Strong patient volumes produced through local referring physician network EMA charting system About the Community: Living in Renton, Washington, offers a mix of suburban comfort, natural beauty, and urban...Local areaImmediate startRelocation package
$25 - $31 per hour
...spreadsheets/software) 2 months in advance. Compliance Monitoring, Service Recovery & Safety On a weekly basis, verify all the provider’s EMA path and lab logs are correctly updated by the MAs and providers and communicate discrepancies to each clinical team asappropriate....Hourly payTraineeshipWork experience placementWork at officeLocal areaMonday to FridayShift work2 days per week- ...M&A or licensing deals are essential. The ideal candidate will also have a background in business development, be familiar with FDA/EMA oncology guidance, and possess the ability to interpret complex biomarker data and high-level biostatistical outputs. The role demands...Shift work
$85k - $94k
...protein and antibody characterization Demonstrated capabilities of reviewing and interpreting data and reports Familiarity with FDA/EMA regulations ICH guidance documents and compendia (US EU) Familiarity with Quality Management Systems and LIMS a plus Familiarity...Local area$218.26k - $305.57k
...engineers, FPGA designers, EEE component specialists, PCB layout engineers, avionics mechanical designers, and electromechanical actuator (EMA) drive electronics engineers. The organization delivers flight-certified hardware on demanding schedules, operating at the...Permanent employmentTemporary workLocal areaImmediate start$190k - $230k
...preferred but not required Minimum 2 years management experience is preferred KNOWLEDGE, SKILLS AND ABILITIES: Knowledge of FDA, EMA and ICH CMC regulations and guidelines for cell therapies Proven track record in preparing, reviewing and executing CMC regulatory documents...For contractorsLocal area- ...executive leadership and Board-level stakeholders, and will oversee all interactions with global health authorities, including the FDA, EMA, and PMDA. Applicants must have a minimum of 15 years' regulatory experience in the biopharmaceutical industry, with a proven track...
- ...functional teams to deliver flight-critical hardware. The role emphasizes leadership, reliability, and hands-on verification, with a focus on servo EMA and pneumatic devices. A passion for safe human spaceflight and mission success is essential. #J-18808-Ljbffr Blue Origin
