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- ...end (from providers, hospitals, facilities, and community partners) through intake and prep, then hands the fully prepped referral to EMA for direct outreach. MIF list referrals are out of scope for this role. The ideal candidate is warm and calm under pressure, catches...SuggestedWork at officeLocal areaImmediate startRemote workMonday to FridayShift workAfternoon shift
- ...pharmacovigilance operations, cross-functional initiatives, or vendor management. Strong knowledge of global PV regulations (ICH, FDA, EMA, etc.). Experience managing external vendors and ensuring compliance with contractual obligations. Excellent organizational,...SuggestedContract workRemote workFlexible hours
$117k - $189.2k
...standards, and applicable ICH guidelines. Ensure clinical programs comply with global health authority regulations, including relevant FDA, EMA, and MHRA requirements, as well as internal standard operating procedures. Provide quality oversight and review of clinical trial...SuggestedFull timeContract workRemote workFlexible hours$29 - $33 per hour
...metrics and contribute to quality improvement initiatives. Ensures that all clinical documentation complies with GCP, ICH, FDA, EMA, and company SOPs. Assists with SOP development and updates related to quality control activities. Supports and ensures strictest...SuggestedHourly payFull timeWork at officeRemote workMonday to Friday$250k - $320k
...Practice (GDP) requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and FDA and EMA expectations. Regulatory inspection leadership: Experience interacting directly with regulatory authorities and successfully...SuggestedContract workRemote work$70.1k - $145k
...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...SuggestedContract workWork at officeLocal areaRemote workWork from homeFlexible hours$109.9k - $179.3k
...drug development Hands-on experience with pharmacology, PK, or PD laboratory data Knowledge of eCTD guidelines, ICH, FDA, and EMA/CHMP nonclinical requirements Proficiency with document authoring and collaboration tools in regulated environments Compensation...Suggested- ...business requirements across Submissions, Registrations, and Content. * Solid understanding of global regulatory processes (FDA, EMA, Health Authorities).Experience supporting regulatory submissions, commitments, correspondence, and archival processes. * Proven experience...SuggestedPermanent employmentFull timeRemote work
$60 - $100 per hour
...interpretation, and regulatory sensitivity. ~ Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a plus. ~ Excellent written communication skills and ability to author detailed grading rubrics and technical documentation....SuggestedContract workFor contractorsRemote work- ...industry with pharmaceutical / biotech companies. eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership...SuggestedContract workWork experience placementRemote work
- ...including 3 or more years in a leadership position. - Strong knowledge of GxP regulations and guidelines, including applicable FDA, EMA, and ICH requirements, with experience applying quality standards throughout the product lifecycle. - Hands-on experience with document...SuggestedFull timeContract work
- ...spoken and written English • Excellent interpersonal, influencing and team building skills • Understanding guidelines (FDA, ICH, EMA and GCP) • Working knowledge of biostatistics, data management, and clinical operations procedures • Ability to act as a mentor/trainer...SuggestedRemote jobFull timeContract workWork at office
- ...regulatory implications of proposed CMC changes and provide risk-based guidance Interpret and apply global regulatory guidance from FDA, EMA, ICH, PMDA, NMPA, and other authorities Provide strategic leadership and mentorship to junior team members Requirements ~...Suggested
- ...in spoken and written English Excellent interpersonal, influencing and team building skills Understanding guidelines (FDA, ICH, EMA and GCP) Working knowledge of biostatistics, data management, and clinical operations procedures Ability to act as a mentor/...SuggestedRemote jobFull timeContract workWork at office
- ...desirable. Experience with TPL work for early development programs and identified life-cycle programs. Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations. Integrity...SuggestedRemote jobWork at officeLocal areaWorldwide
$176.1k - $287.3k
...NONMEM, Monolix, Simulx, MATLAB/Simbiology, and R Track record delivering analyses supporting regulatory submissions with direct FDA, EMA, or PMDA engagement Hands-on experience with broad quantitative and computational tools and strong publication record...- ...experience in both regulatory affairs and compliance programs Demonstrated expertise in FDA and international regulatory strategy (EMA, ICH) Strong knowledge of GDPR, data privacy law, and data protection frameworks Experience leading ethics and compliance...
- ...treatment experience Therapeutic expertise and clinical knowledge in Psychiatry Working knowledge of safety databases, FDA/ICH/EMA guidelines, and Good Clinical Practice For Senior level: 1-2 years industry experience in CRO or pharmaceutical clinical trials...Remote work
- ...payer/HTA environment to inform COA measurement strategy for clinical trials and interfaces with external global regulatory [e. g. FDA, EMA etc. ] to support labeling negotiations. - Partners with cross-functional stakeholders and country affiliates to support global HTA...Full timeWork experience placement
- ...Proficiency in SAS or R for statistical analysis and data programming Experience with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA) CNS drug development experience and expertise in survival analysis or adaptive design highly desirable...Remote work
- ...optimize content strategies. Skills: ~ Experience with digital marketing strategies and SEO best practices. ~ Knowledge of FDA, EMA, or other regulatory guidelines for healthcare communications. ~ Proficiency in content management systems and marketing automation...Remote job
$115.26k - $149.16k
...hematological cancers / cell therapy. Scientific background and experience with lab data handling. Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management. Experience in managing clinical data management...Full timeFor contractorsLocal areaFlexible hours- ...right path forward, using approved AI tools to draft stronger appeals and move faster. Work in client systems. Navigate ModMed (EMA), EZDERM, Nextech, eCW, and other modern EHR and practice management platforms fluently. Make the operation better. Flag recurring...Remote jobFull timePrivate practiceWork at office
- ...GxP / GAMP 5 and internal model governance Support the qualification of AI/ML solutions against evolving regulatory expectations (EMA reflection paper on AI, FDA AI/ML guidance, EU AI Act obligations for high-risk systems) in partnership with Quality, DT/BIS and GPS...Remote jobWork at office
$147k - $180k
...compliance, quality systems, and regulatory adherence across sponsored studies. The role ensures alignment with ICH GCP guidelines, FDA/EMA requirements, and company standards while managing vendor relationships, audits, and quality investigations. Responsibilities...Work experience placement- ...document. Prepare documents for publishing readiness, when applicable. Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as...Remote jobInterim roleFlexible hours
- ...development. Develop and participate in special projects for respective teams or CTPS initiatives. • Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues to assigned responsibilities as they impact on CTPS processes, procedures,...Full time
- ...stage biotech/pharma with knowledge of labeling, promotional review, post-marketing commitments ~ Mastery of ICH guidelines, FDA and EMA post-marketing regulations, and CMC lifecycle requirements ~ Small molecule and cardiometabolic disease experience preferred...
- ...strategies integrating clinical, nonclinical, CMC, and product development objectives Lead health authority interactions with FDA, EMA, TGA, and other regulatory agencies Prepare briefing packages, meeting requests, regulatory submissions, and post-meeting follow-...
$123.93k - $160.38k
...clinical data management processes including query management, site concerns, and data collection standards Familiarity with FDA, EMA, ICH, and GCP requirements Strong communication and cross-functional collaboration skills Detail-oriented with ability to ensure...Full timeFor contractorsLocal area