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$212k - $318k
...data • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards; active involvement in inspection readiness activities, internal audits and external inspections...SuggestedContract workWork experience placementRemote workWorldwideFlexible hours$24 - $26 per hour
Job Title Base Compensation: USD 24.00 - 26.00 Paid Hourly 23301 S. Wilmington Ave Carson, California, 90745 United States DucommunSuggestedHourly pay- ...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
- ...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
- ...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 workWork at officeImmediate startFlexible hoursShift work
$308k
...Regulatory & External Engagement Act as a key medical contributor in regulatory interactions with global health authorities (e.g., FDA, EMA). Support preparation and review of regulatory documents, including protocols, CSRs, IBs, IND/CTA submissions, and briefing...SuggestedRemote workWorldwideFlexible 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 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 workInterim roleLocal areaImmediate 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 workTemporary workImmediate startFlexible hours
$120k - $135k
...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 workWork at officeImmediate startRemote workWorldwideFlexible hours- ...Technology & Systems Master the technology suite used in daily work, including Microsoft Office (Excel, Word, Outlook), ModMed/EMA, Zoom, and Klara, to collaborate with teams and support patients effectively. Document all interactions, research, and follow-up actions...SuggestedFull timeWork experience placementWork at officeRemote work
$95k - $175.7k
...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 workRemote workWork from homeFlexible hours2 days per week3 days per week
- ...steam, water systems) Process engineering in GMP/biopharmaceutical environments Engineering project lifecycle management FDA, EMA, and cGMP regulatory compliance Engineering documentation (PFDs, P&IDs, URS, FAT/SAT/IQ) Root cause analysis and CAPA management...SuggestedFor contractors
SGS Consulting
Californiaa month ago $135k - $200k
...Who are we? Ema is building the next generation AI technology to empower every employee in the enterprise to be their most creative and productive. Our proprietary tech allows enterprises to delegate most repetitive tasks to Ema, the Universal AI employee. We are founded...Full timeWork experience placementWork at office3 days per weekEma
San Francisco, CA1 day ago- ...responsible for independently conducting thorough review of batch production records and supporting documentation to ensure products meet FDA, EMA, and internal QMS requirements prior to disposition and release. Applies working knowledge of cGMP regulations, SOPs, and quality...Work at office
Pyramid Laboratories Inc
Costa Mesa, CA12 days ago $135k - $300k
...About Ema Ema is building the world’s leading Agentic AI platform to transform enterprise productivity. We enable organizations to delegate repetitive tasks to Ema, the Universal AI Employee, delivering 10x gains in workforce efficiency, across functions. Founded by former...Full timeWork experience placementEma
San Francisco, CA1 day ago$295k - $339k
...Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.Support the Medical Monitors Medical Lead and other team leads in clinical sections of...Full timeLocal area- ...assessments (FMEA, impact assessments) SOPs, deviation investigations, and CAPAs Ability to support regulatory inspections and audits (FDA, EMA, internal, or client audits). Strong technical writing skills with attention to detail and data integrity. Proficiency with common...
$40 - $42 per hour
...as pharmaceuticals, biotechnology, medical devices, or cell & gene therapy. ~ Solid understanding of cGMP regulatory standards—FDA, EMA, ICH guidance preferred. ~ Familiarity with quality management systems and GDP requirements in a GMP environment. ~ Experience in...Hourly payContract workTemporary workLocal areaKelly Services
South San Francisco, CA10 days ago$101.5k - $105k
...and demonstrated ability to develop long-term strategic partnershipsExperience with regulatory compliance requirements including FDA, EMA, and other global standards that govern life sciences facility operationsLocation: Main site: San Diego, CA & 1more location(approx....Full timeLocal areaShift work$188.2k - $263.6k
...toxicology/pathology; preference for individual with experience in ophthalmology.Strong GLP and ICH guidance knowledge; Experience with EMA/FDA CTA/IND submissions and regulatory interactions preferred.Ability to develop comprehensive preclinical safety approaches with...Work at officeLocal areaRemote work- ...escalation processes to minimize impacts to schedule and cost.Ensure compliance with regulatory requirements and industry standards (GMP, FDA/EMA expectations, local building and safety codes) and support commissioning/validation activities.Mentor and lead multidisciplinary...For contractorsFor subcontractorLocal area
$150k - $165k
...and CRO management, data collection, study protocol compliance.Solid understanding of US and global regulations and guidelines (FDA, EMA, ICH).Experience in working in a highly matrix environment and ability to execute in the context of internal and external (vendor) cross...$145k - $165k
...experienceExperience supporting complex global Phase III clinical trialsCell therapy or Oncology ExperienceStrong understanding of ICH-GCP, FDA, EMA, and applicable global regulatory requirementsDemonstrated proficiency in technology use, documentation practices, and sound business...Local areaRemote work- ...(k) submissions), and continual learning in a regulated environment. Understanding of clinical trial design, GxP principles, and FDA/EMA regulatory requirements, particularly for medical device submissions such as PMA and 510(k). Familiarity with CDISC standards (SDTM,...Interim role
$209k - $288k
...changes, conflicts resolutions, and effective partnershipPreferred Skills:Past regulatory experiences, including interactions with FDA/EMA/PMDA and BLA/NDA/MAA submission experiencesExperiences in nephrology or immunology a plusPeople manager with track record of staff...Full timeTemporary workWork experience placementLocal area- ...academic research.Understands drug development phases and the nature of associated clinical trials across phases.Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Strong communication and organizational skills....Full timeFor contractorsWork at officeLocal areaFlexible hours
$275k - $360k
...metabolismIn-depth knowledge of relevant global regulatory requirements and guidelines related to clinical pharmacology studies, including FDA, EMA, and ICH guidelines. Ability to interpret and apply these regulations effectively in a practical context. Experience with regulatory...Contract work
