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$220.7k - $272.7k
...prioritize. ~Experienced in study level work including authoring SAP and TFL specification. ~Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance. ~Solid understanding of mathematical and statistical principles; experience in statistical...SuggestedFull timeRemote workWork from homeUltragenyx Pharmaceutical
Remote6 days ago- ...guidelines is preferred. ~Familiarity with CDMO contract structure (Fee-for-service, Milestone-Based, FTE-Based Pricing) is strongly preferred. ~Familiarity with GMP (Good Manufacturing Practices) and regulatory requirements (FDA, EMA, MHRA) strongly preferred....SuggestedFull timeContract workWork experience placementRemote work
Sharp Packaging Solutions, part of UDG Healthcare plc
Remote1 day ago $105k - $145k
...for each pod. ~Regulatory Compliance ~Maintain up-to-date knowledge of global veterinary pharmacovigilance regulations (e.g., EMA, FDA, USDA, VICH). ~Ensure global compliance with internal SOPs and external global regulatory requirements. ~Partner with...SuggestedFull timeZoetis
Remote2 days ago$160k - $190k
...Scientific Domain Leadership ~Ensure products meet scientific rigor and validation requirements ~Translate regulatory guidance (FDA, EMA) into product capabilities ~Partner with Scientific R&D to incorporate cutting-edge methodologies ~Guide technical trade-offs...SuggestedFull timeSimulations Plus
Remote4 days ago- ...in need. Remote - USA (East Coast) Over the past 5 years, we have worked with: ~94% of all Novel FDA Approved Drugs ~95% of EMA Authorized Products ~Over 200 Studies across 73,000 Sites ~675,000+ Trial patients No matter what your role is, you’ll take...SuggestedFull timeRemote work
Syneos Health
Remote4 days ago $180 per hour
...~Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA. ~Write and edit a wide range of regulatory documents, including but not limited to: ~Clinical trial protocols and amendments...SuggestedHourly payTemporary workVir Biotechnology
Remote2 days ago$250k - $300k
...required ~Demonstrable experience working directly for a sponsor company ~Strong knowledge of CDISC standards (SDTM, ADaM) and FDA/EMA submission requirements ~Proven leadership of a programming team or function ~East Coast based only Requirements ~...SuggestedAstera Search
Remote17 hours ago$170k - $220k
...submission standard ~Support data delivery for CSR packages and regulatory submissions ~Ensure alignment with CDISC standards and FDA/EMA requirements ~Contribute to programming process development and standards Qualifications ~Bachelor's or Master's degree in...SuggestedFull timeAstera Search
Remote17 hours ago$125k - $175k
...monitoring, and closing out clinical trials is desirable. ~Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations. ~Demonstrated understanding of cross-functional processes including site selection, study start-up, clinical operations...SuggestedFull timeTemporary workEverest Clinical Research
Remote17 hours ago$163.8k - $177.4k
...requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy. ~Ability to communicate effectively with vendors regarding project scope,...SuggestedFull timeContract workWork at officeFlexible hoursBridgeBio Pharma
Remote17 hours ago- ...Community Manager, you’ll sit at the intersection of content, brand, community, and experimentation. You’ll help shape how the world sees Ema and create an influential community of enterprise leaders rethinking how work gets done with AI. Social Media & Content Creation...SuggestedFull time
Ema
Remote2 days ago $110.49k - $149.49k
...Assessments; RMPs and variations) and responses to information requests under SME guidance. ~Tracks requirements across regions (FDA/EMA/HC/other NRAs), aligning REMS deliverables with global risk minimization materials and evaluation plans. ~Works with project teams...SuggestedFull timeWork at officeFlexible hoursSyneos Health Careers
Remote17 hours ago$173.8k - $217k
...other global regulatory submissions as lead or co-statistician; support responses to health authority queries ~Stay current with FDA, EMA, and ICH guidance on statistical methodology, and real-world evidence (RWE) ~AI Interface Setup & Implementation ~Design and...SuggestedFull timeWork at officeBridgeBio Pharma
Remote17 hours ago$90 - $120 per hour
...development and regulatory submission processes, including familiarity with ICH guidelines and major health authority expectations (e.g., FDA, EMA). ~Exceptional attention to detail with strong analytical and critical‑thinking skills, including the ability to identify...SuggestedHourly payTemporary workVir Biotechnology
Remote2 days ago$125k - $150k
...student lifecycle. Formed through the merger of the former Educational Records Bureau (ERB) and the Enrollment Management Association (EMA), E3n builds on nearly a century of collective expertise in assessment, enrollment, and student development. E3n exists to deepen...SuggestedFull timeWork at officeRemote workTalentED Advisors
Remote17 hours ago- ...GCP) Certification. ~ICH-GCP training certification (current and up to date). ~Clinical research compliance training (e.g., FDA, EMA regulatory training). ~Lean Six Sigma Green Belt or higher (preferred in BPO operational environments). Skills & Competencies...Full timeWork from home
Sagility
Remote2 days ago $105.28k - $150.4k
...and periodic review programs. ~Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.). ~Develop and maintain validation templates, SOPs, and training programs. Qualifications ~Bachelor’s degree in...Full timeAstellas Pharma
Remote7 days ago$130k - $180k
...oncology studies ~Support data delivery for CSR packages and regulatory submissions ~Ensure compliance with CDISC standards and FDA/EMA requirements ~Contribute to programming documentation and process development Qualifications ~Bachelor's or Master's degree...Full timeAstera Search
Remote17 hours ago- ...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...Contract workWork experience placementRemote work
- ...all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. This includes, but is not limited to, the following: # Schedule and conduct...Remote jobFull timeContract workWork at officeWork from homeWorldwide
- ...all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. # Communicate project action items and key decisions through timely minutes...Remote jobFull timeContract workWork at officeImmediate startWork from homeWorldwide
$163.8k - $177.4k
...natively utilizing Research tracking principles. Practical operational familiarity authoring regulatory filings, interpreting FDA/EMA policies, and applying ICH guidelines natively using Technical Writer documentation standards. Demonstrated ability to adapt to...Full timeContract workWork at officeImmediate startRemote workWork from homeWorldwideHome officeFlexible hoursShift workBridgeBio
Remote6 days ago- ...pharmaceutical, biotech, and medical device companies operate, including their global regulatory and compliance pain points (e.g., FDA, EMA, GxP). ~10+ years of professional sales experience, with a significant portion dedicated to B2B SaaS commercial sales leadership on...Remote workWorldwide
- ...system and edit rules in collaboration with IT and automation partners, growing into broader ownership of EHR/PM (Modernizing Medicine / EMA) configuration. Support automation and integration initiatives that reduce manual work, rework, and error across professional, ASC...Permanent employmentFull timeWork experience placementWork at officeRemote work
- ...engagement. Operational Oversight & Compliance Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions. Maintain labeling documentation within eDMS and regulatory tracking platforms;...Remote jobWork at officeLocal areaWorldwide
$221k - $286k
...Inflammation a plus)Familiarity with MLOps, CI/CD, and AI Platform Architecture in Regulated (GxP) environmentsPrior engagement with FDA, EMA, or industry consortia (e.g., TransCelerate, PhRMA, CDISC) on AI/digital innovation/clinical innovation. Experience with agentic...Full timeFor contractorsLocal areaRemote work- ...knowledge, skills, and experience. Certain roles may be eligible for variable compensation, equity, and benefits. Company Description Ema Unlimited is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and...Full time
Ema
Remote7 days ago $176.1k - $287.3k
...and R. Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA). Hands-on experience with a broad range of quantitative and computational tools and a strong publication record....Remote job- ...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
- ...and draft all necessary comparability protocols. ~Ensure all analytical activities comply with current regulatory guidelines (FDA, EMA, and ICH). ~Prepare and review regulatory submissions, including INDs and CTAs, with a focus on analytical methodologies. ~...Full timeWork at officeRemote workFlexible hours
Syner-G
Remote7 days ago
