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... 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 ...

Company: Syneos Health Careers (1 week ago)

... vendor relationships and functional service provider (FSP) partnerships In-depth understanding of FDA and ICH/GCP regulations and guidelines related to data capture and data management processes ...

Company: Kailera Therapeutics (1 week ago)

... . Bonus Points For Experience working in early-stage or rapidly scaling companies. Familiarity with FDA regulations and running trials in the US. A background in science, engineering, or regulatory affairs. Why ...

Company: Sava (1 week ago)

... : Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA).? Industry Best Practices: Stay up to date with emerging trends and best practices in clinical ...

Company: Pop Science (1 week ago)

... and patients to develop a strong product pipeline to be manufactured at its CA, CE, ISO, US FDA approved facilities. At Clinisupplies, we want to make a difference in healthcare, that means ...

Company: Clinisupplies (1 week ago)

... quality standards. Ensure clinical trial conduct aligns with ICH/GCP guidelines, FDA/EMA regulations, and internal SOPs. Partner cross-functionally with global teams, vendors ...

Company: Planet Pharma (1 week ago)

... . Ensure all molecular biology processes align with GMP, GLP, and regulatory expectations from the FDA, EMA, and other governing bodies. Represent the company in scientific conferences, regulatory discussions, and strategic ...

Company: CPL Healthcare (1 week ago)

... GCP and industry standards. Proficiency in R, EAST, and experience with CDISC standards. Experience with FDA and international regulatory interactions. Experience designing adaptive trials. About Alnylam: Alnylam ...

Company: Alnylam Pharmaceuticals (1 week ago)

... Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then ...

Company: Quotient Sciences Limited (1 week ago)

... such as PTM profiling, DAR, glycan analysis, or comparability studies. Understanding of FDA/EMA expectations for CMC filings, comparability protocols, and cGMP analytical validation. Familiarity ...

(1 week ago)

... , central monitoring, and oversight monitoring strategies. Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements for central monitoring and oversight. Previous clinical monitoring ...

Company: PTC THERAPEUTICS (1 week ago)

... actions. Ensure compliance with relevant industry standards (e.g., GxP, ISO, FDA 21 CFR Part 11) and support regulatory audits and inspections. Champion best practices ...

Company: CluePoints (1 week ago)

... System and IEC 60601 and ISO 14971 standards. Familiar with Medical Device Regulations (FDA, MDR, CE). Creative, flexible, hands-on sales professional that’s comfortable ...

(1 week ago)

... and logistics standards including to meet ISO9001, ISO22716, ISO14001, TGA and FDA accreditations. ● Ensure compliance with the required importation, storage and transportation ... development skills across multiple locations and cultures ● Familiarity with GMP and FDA requirements. ● Hands on - proactive approach with strong problem solving ...

Company: Medik8 (2 weeks ago)

... . - Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design ... . - Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design ...

Company: QIAGEN Gruppe (2 weeks ago)

... communication skills in English A working knowledge of regulatory requirements, including FDA, EMEA, and VICH/ICH guidelines Excellent problem-solving skills and the ability to work ...

Company: SRG Job type: temporary (2 weeks ago)

... Directive 2001/83/EC 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment. 2 Years experience gained within an aseptic ...

Company: Sterling Engineering (2 weeks ago)

... of Allen Bradley and Siemens PLCs. Familiarity with pharmaceutical industry standards (GMP, FDA). Experience with start-up and commissioning projects. What We Offer Competitive salary Career development opportunities ...

Company: Cpl Resources (2 weeks ago)

... in a Pharmaceutical, Brewery, Dairy and Food Industry. Worked in a regulated Industry (FDA, IMB, NSAI) Good working knowledge of preventative maintenance programs for a ...

Company: Veolia Ireland (2 weeks ago)

... and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations. Responsible for ensuring that all equipment, Utilities are tested in compliance with project related ...

Company: Life Science Consultants (LSC) (2 weeks ago)