development and development of medical devices is a plus. Strong knowledge of Clinical Development and Research operations and regulatory landscape. Deep knowledge of GCP, GLP, GPVP, GCP for Labs and a general understanding of GMP. Expert in process development, industry standard problem-solving approaches, in alignment with Lean and Lean more »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
development and development of medical devices is a plus. Strong knowledge of Clinical Development and Research operations and regulatory landscape. Deep knowledge of GCP, GLP, GPVP, GCP for Labs and a general understanding of GMP. Expert in process development, industry standard problem-solving approaches, in alignment with Lean and Lean more »
projects on behalf of vaccine manufacturers. The Group has extensive experience in assay development and validation and operates to several Quality Systems including GCP, GLP and GMP. Main duties of the job Job description The purpose of this job is to perform routine duties related to and to provide general more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
will have responsibility for duties including: Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies. Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and … process, including in the collaboration with C(D)MOs. Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may more »
Palo Alto, California, United States Hybrid / WFH Options
Jazz Pharmaceuticals
is a critical part of an innovative team that supports the company's drug discovery/development effort. Conceptualizes, develops, revises, and finalizes toxicology (GLP and non-GLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB … DSUR, PSUR, etc.) to ensure regulatory compliance. Manages and monitors nonclinical studies (GLP and non-GLP) at external CROs per Jazz standards and ensures that global regulatory/compliance requirements are met/exceeded. Critically reviews and edits CRO nonclinical toxicology study reports, analyzes and interprets data, defines PK/… to synthesize and communicate complex information. Capacity to propose practical mitigation (de-risking) strategies. Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations. Required experience in authoring non-clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB more »
