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$288.03k - $353.64k
...health authority questions, and labeling discussions. Ensure pharmacometrics activities are conducted in alignment with applicable FDA, EMA, ICH, and global regulatory expectations for model-informed drug development, population PK, and exposure-response analyses. Vendor...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$200.85k - $227.32k
...compliance with relevant regulatory requirements (e.g., FDA regulations).Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for regulatory meetings, responses to health authority questions, and preparation for advisory...Suggested$260.97k - $309.34k
...management processes to ensure effective trial execution. Quality Assurance and Regulatory Compliance Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for clinical research. Partner with Quality Assurance to ensure ongoing inspection readiness and...Suggested$177.4k - $238.96k
...regulatory compliance and alignment with regulatory CMC strategies. Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment. Support regulatory inspections, as required. Qualifications...SuggestedFlexible hours$259.08k - $396.2k
...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 through...SuggestedLocal areaFlexible hours$229.17k - $256.25k
...with contractual obligations, timelines, and performance metrics. Quality and Regulatory Compliance Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements. Partner with Quality Assurance on system validation, inspection-readiness, audits and...Suggested$222.29k - $294.01k
...submissions including INDs, NDAs, BLAs, and MAAs. Partner with Regulatory Affairs during interactions with regulatory authorities (FDA, EMA, MHRA, etc.) on product safety matters. Collaborate with Regulatory Affairs to ensure appropriate inclusion of safety information in...Suggested$133.66k - $161.97k
...systems.Minimum 3 years of leadership experience, including direct supervision and development of team members.Solid knowledge of FDA and EMA regulations governing pharmaceutical and biotechnology operations.Proficiency in advanced Root Cause Analysis (RCA) tools and...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$176.6k - $294.3k
...emerging regulatory frameworks governing AI-enabled drug development. Experience interacting with global regulatory agencies (e.g. FDA, EMA, MHRA, PMDA, Health Canada Experience leading enterprise AI transformation initiatives. Strong publication record and scientific...SuggestedPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...to ensure regulatory excellence. The ideal candidate has 6+ years GxP Biopharma experience, strong RCA/QRM skills, and 3+ years of leadership. Excellent knowledge of FDA/EMA rules and a focus on Right First Time is required for success. #J-18808-Ljbffr Biopharma CareersSuggested
$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,...SuggestedContract workWorldwide$229.26k - $277.8k
...functionally and to develop and maintain strong business partner relationships. Demonstrated ability to work effectively with US FDA, EMA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards. Demonstrated record...SuggestedNational Guard Employment Network
Bothell, WA3 days ago$119.1k - $186.3k
...support development of compliant business systemsRepresent PACCAR in associations such as Truck and Engine Manufacturers Association (EMA). Disseminate association information within PACCAR and develop PACCAR positions, in coordination with ECO managementSupervise and...SuggestedTemporary work$45 - $65 per hour
...via Association of Energy Engineers) ; f. Is an Energy Management Professional (EMP) certified by the Energy Management Association (EMA) ; g. Has a Bachelor of Applied Science degree in Sustainable Building Science Technology from South Seattle College (or equivalent...SuggestedHourly payFull timeContract workTemporary workApprenticeshipWork experience placementLocal areaShift workNight shiftAfternoon shiftRenaissance Seattle Hotel
Seattle, WA27 days ago$115k - $126.5k
...practices for a science and risk-based approach to qualification of systems and processesWorking knowledge of US FDA CFRs and European EMA, including ICH regulations Experience with quality risk management Experience authoring, reviewing, and approving validation...Full timeTemporary workFor contractorsWorldwideFlexible hours$120.2k - $140k
....ServiceNow or equivalent ITSM tool experience for ticketing and change management.Experience supporting regulatory submissions (FDA/EMA) from a systems/platform readiness perspective. The wage range for this role takes into account the wide range of factors that are considered...Permanent employmentLocal areaRemote workVisa sponsorship$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 payWork experience placementWork at officeLocal areaMonday to Friday- ...workstreams — managing design milestones, commissioning activities (IQ/OQ/PQ), vendor coordination, and regulatory readiness across FDA/EMA environments.Partner with client IT, Quality, Manufacturing, and Regulatory teams to ensure integrated solutions meet operational...Full timeWork experience placementLive inWork at officeLocal area
- ...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
$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- ...Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks is essential, with a preference for candidates with EMA and ex-US experience. The ideal candidate will have strong executive communication skills, the ability to influence senior leadership...
$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- ...proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...Contract workRemote workFlexible hours
$210k - $260k
...licensure (BLA/MAA) and lifecycle management. You will serve as the primary regulatory representative to global health authorities (FDA, EMA, etc.), ensuring alignment with business objectives and driving innovative approaches to accelerate the development of transformative...Temporary workLocal area- ...ophthalmology and retina programs. The role requires expertise in both U.S. and ex-U.S. regulatory agencies, particularly the FDA and EMA. The candidate must be adept at guiding regulatory aspects of clinical development planning and be prepared to take on the challenge...
$255k - $424.9k
...enforcementOwn GxP AI validation strategy and audit readiness across all regulated environmentsLead AI regulatory intelligence e.g. FDA, EMA, EU AI Actand emerging global frameworks, coordinated with Legal and business units to get ahead of compliance obligationsPartner at...Full time- ...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
$56.4k - $95.9k
...proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...Contract workWork at officeRemote workFlexible hours$320k - $400k
...in preparing global regulatory submissions and agency interactions. Participate in meetings with health authorities, including FDA, EMA, and other international agencies. Support preparation of briefing documents, submission packages, and responses to regulatory inquiries...Work at office2 days per week
