- Ascendis Pharma (Palo Alto, CA)
- …with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory ... risk mitigation strategies, and influences project teams and sub teams across international site locations. + Provides regulatory information and guidance for… more
- Stanford University (Stanford, CA)
- …Stroke and Neurocritical Care, and representing the university with external regulatory agencies, both domestic and international . Responsibilities will include ... Regulatory Specialist **School of Medicine, Stanford, California, United...determine how to implement within unit. Apply knowledge of international , federal, state and local regulations as well as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development and authorization/clearance/approval. + In-depth knowledge of applicable IVD regulatory requirements, international standards and guidance in the ... help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and execute Precision… more
- Abbott (Pleasanton, CA)
- …influence. + Experience managing global audit programs and working with international regulatory bodies. + Familiarity with enterprise-level quality systems ... live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify… more
- BeOne Medicines (Emeryville, CA)
- …formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting ... project timelines. Clinical regulatory documents include, but are not limited to study...and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. **Essential Functions of the job:** +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …customer satisfaction. * Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other ... of regulatory intelligence for projects related to US and international labeling remediation. * Effectively communicate regulatory strategies to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …US Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …customer satisfaction + Support the monitoring and interpreting of current and new regulatory requirements and international standards for US and RoW + Support ... **Job Description Summary** As Staff Regulatory Affairs Specialist, you will be responsible for...Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product… more
- Valvoline Global (CA)
- …framework that enforces robust policies, standards, and controls. Ensure compliance with international regulatory and industry standards (eg, SOX, GDPR, PCI), ... and compliance goals, playing a pivotal role in meeting regulatory requirements such as SOX, GDPR, and other ...regulatory requirements such as SOX, GDPR, and other international cyber security standards and frameworks such as the… more
- Bristol Myers Squibb (San Diego, CA)
- …plan consistent with the development strategy, program goals, and the US/ international regulatory guidance for radiopharmaceuticals. + Collaborate with DMPK, ... population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization. +… more
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