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- ...schedules with key pharmaceutical milestones (e.g., IND, clinical phases, NDA/BLA). Ensure adherence to relevant regulations (FDA, EMA, GCP, GMP) and Aniesispharma's quality standards. Maintain comprehensive project documentation compliant with pharmaceutical industry...SuggestedRemote jobWork at office
- ...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...SuggestedContract workInterim roleLocal areaImmediate startRemote workFlexible hours
- ...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...SuggestedContract workFlexible hours
- ...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...SuggestedContract workInterim roleImmediate startRemote workFlexible hours
- ...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...SuggestedContract workFlexible hours
- ...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...SuggestedContract workFlexible hours
$120k - $135k
...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...SuggestedRemote jobContract workWork at officeImmediate startWorldwide$79.8k - $139.6k
...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...SuggestedContract workFlexible hours- ...professionally Collaborative, transparent, and team-oriented approach Technical & Regulatory Expertise Thorough knowledge of FDA and EMA regulations, ICH Guidelines, and GCP requirements Strong working knowledge of Microsoft Word, Excel, and PowerPoint Ability to...SuggestedContract workInterim roleImmediate startRemote workFlexible hoursShift work
$95k - $105k
...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...SuggestedContract workRemote workWorldwideFlexible hours- ...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 workRemote workFlexible hours
Syneos Health/ inVentiv Health Commercial LLC
Wisconsin1 day ago - ...CGMPs to everyday work.Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.Executes procedures of high complexity with high quality.Advanced understanding of pharmaceutical...SuggestedFull timeWork experience placementWork at officeLocal area
$190k - $230k
...TrainingCollaborate with Quality team on design and delivery of GxP training programs (GMP, GLP, GCP, GDP) to ensure compliance with FDA, EMA, and other global regulatory requirements.Partner with Quality, Compliance & Regulatory leadership to identify capability, engagement...SuggestedFull timeFor contractors$200k - $230k
...modeling, dose optimization, and model-informed drug development principles.Experience supporting regulatory interactions with FDA, EMA, and other global health authorities.Knowledge of PBPK, QSP, mechanistic modeling, or systems pharmacology approaches is highly desirable...Suggested- ...relevant experienceMust be able to ensure data integrity and full compliance with company SOPs, specifications, cGMP, ICH, FDA, and EMA requirements, while integrating and interpreting data across multiple disciplines while commanding the full Biologics processDemonstrated...SuggestedFull timeContract workLocal areaMonday to Friday
- ...functional teams responsible for optimizing portfolio deliveryStrong familiarity with regulated pharmaceutical development and FDA, EMA, and other MOHs globallyAbility to influence outcomes, utilizing effective communication skills across functions and on the executive...
- ...successfully leading Quality organizations, preferable in a matrix-style organization.Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.Proven experience in driving substantial improvements of quality performance across a...Full timeLocal area
- ...technical skills and performance of department members Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary Supporting regulatory information requests from customers as it pertains...
$130k - $150k
....Support responses to regulatory agency questions and inspections.Ensure analytical activities comply with applicable GMP, ICH, FDA, EMA, and other regulatory requirements.Participate in quality investigations, change controls, risk assessments, and CAPA activities as needed...Contract work$150k - $170k
...stage clinical programs and/or commercial launches, including PPQ and BLA/NDA-supporting activities. Strong working knowledge of FDA, EMA, and ICH GMP requirements; experience supporting regulatory inspections at CDMOs. Excellent written and verbal communication skills,...Contract work- ...readinessApply Quality by Design (QbD) principles and statistical tools for process characterization and PPQ readinessEnsure compliance with FDA, EMA, and ICH guidelines for process validation and lifecycle managementEstablish and maintain SOPs for mRNA synthesis and purification to...Full timeLocal area
- ...independently while recognizing when to consult your supervising physician. Become proficient in managing a patient load of 30+ per day using EMA, our Electronic Health Record. Provide guidance and direction to clinic staff as needed. Qualifications A minimum of 2-5 years of...Full timeLocal areaFlexible hours
- ...operationsExperience building reusable IP: accelerators, toolkits, reference architectures, or commercial offeringsFamiliarity with MLR/PRC review, FDA/EMA standards, or evidence-based content workflows is a genuine plusA demonstrated ability to learn new domains quicklyCompensation at...Full timeLive inWork at officeLocal areaShift work
- ...Familiarity with Orbitrap platforms or other high-resolution mass spectrometry systems. Knowledge of regulatory guidelines including FDA, EMA, and ICH bioanalytical method validation guidance. Experience working in a GLP/GCP-regulated environment (CRO or pharmaceutical/...Full timeTemporary workCasual workInternshipMonday to FridayFlexible hours
- ...~0–2 years of experience in quality or manufacturing environments ~ Preferred certifications: IATF, Lead Auditor, Lean/Six Sigma, EMA, VDA ~ Strong understanding of CAPA, APQP, and audit processes ~ Excellent communication and analytical skills ~ Familiarity with...Immediate start
KEM KREST
Pleasant Prairie, WI2 days ago - ...in lieu0–2 years of experience in quality or manufacturing environmentsPreferred certifications: IATF, Lead Auditor, Lean/Six Sigma, EMA, VDAStrong understanding of CAPA, APQP, and audit processesExcellent communication and analytical skillsFamiliarity with industry standards...
KEM KREST
Pleasant Prairie, WI1 day ago - ...environments. The CSV Engineer will author validation deliverables—including protocols, reports, and SOPs—ensuring compliance with FDA, EMA, and global regulatory expectations. Key Responsibilities: Develop and maintain Design Specifications (DS) for computerized and...Full timePart timeFlexible hours
Eliquent Life Sciences
Madison, WI4 days ago $85k - $95k
...qualification activities. Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents. Preferred Prior experience with use of...Work at officeArrowhead Pharmaceuticals, Inc.
Verona, WI4 days ago$132.22k - $158.4k
...submissions to the FDA to support development programs and Collegium marketed products Ensure regulatory submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable regulatory requirements Collaborate with internal stakeholders in Commercial, Medical...Work at officeLocal areaCollegium Pharmaceutical, Inc.
Stoughton, WI3 days ago$169.22k - $253k
...transfer, and method lifecycle management. ~ Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, Q8, Q14; FDA and EMA guidance's). ~ Proven leadership skills and experience managing teams or cross-functional technical groups. ~ Experience with...Full timeContract workTemporary workLocal areaRemote workWorldwideFlexible hoursOtsuka America Pharmaceutical Inc.
Madison, WI5 days ago
