- Gilead Sciences, Inc. (Foster City, CA)
- …collaborative with our stakeholders to advance Gilead's business strategy and ensure high- quality submissions to regulatory health authorities. Quality ... We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster… more
- Taiho Oncology (Pleasanton, CA)
- …lead one or two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading regulatory sub-team and ... are consistent with company objectives. The incumbent directs the project/product teams' regulatory activities to ensure high quality , regulatory integrity,… more
- BeiGene (Emeryville, CA)
- …support BeiGene's corporate vision, mission, and values. As the Head of Global Regulatory Operations, the SD will lead key functions (Submission Operations ... key programs and industry best practice submission processes. The SD will successfully lead the Global Regulatory Affairs organization in identifying and guiding… more
- Gilead Sciences, Inc. (Foster City, CA)
- … control strategies. + Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership ... teams. + Promotes continual improvement for analytical control strategies, quality compliance/business processes, and regulatory filing content taking… more
- Stryker (Fremont, CA)
- …Here are 10 reasons to join our Regulatory Affairs/ Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, Quality System Regulation, export requirements, and regulatory requirements… more
- Taiho Oncology (Pleasanton, CA)
- …(TPC) and external consultants/contractors. Manages the development and preparation of high- quality regulatory submissions including NDA's, MAA's, INDs, CTAs, ... and other related areas. + In conjunction with Quality Assurance, manages regulatory compliance for sponsor...well in a team environment and the ability to lead others. + Working knowledge of project management. The… more
- AbbVie (South San Francisco, CA)
- …requirements. + Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & ... with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP). Qualifications… more
- Abbott (Alameda, CA)
- …experience in a regulated industry (eg, medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research ... our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist,** as part of the Regulatory Affairs Asia Pacific… more
- Jacobs (Oakland, CA)
- …helping our clients secure our world's natural resources. We are looking for a regulatory specialist and permitting lead to support our clients in central and ... Quality Act (CEQA) compliance. Work will include managing regulatory complexities and permitting for a range of projects,...and federal level. * Acting as a permitting task lead on projects. * Preparing scopes of work and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster ... direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA Business… more
- Meta (Burlingame, CA)
- **Summary:** The Material regulatory compliance (MRC) specialist within the RL Quality and Compliance team will lead and champion MRC compliance across RL ... ideally in the consumer electronics space. **Required Skills:** Materials Regulatory Compliance Specialist Responsibilities: 1. Build and maintain full material… more
- Abbott (Alameda, CA)
- …insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements. * Lead and/or contribute to ... Quality Management System at Abbott. Reports to the Regulatory Compliance Manager for the business unit. **What You'll...Manager for the business unit. **What You'll Work On** * Lead , mentor and motivate a team of Quality… more
- Gilead Sciences, Inc. (Foster City, CA)
- …We empower our leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster ... help create possible, together. **Job Description** **Senior Director, RWE Inflammation Product Lead ** **Location: Position can be based at:** Foster City, CA or… more
- Pfizer (South San Francisco, CA)
- …decision-making. **ROLE SUMMARY** The **Senior Director, HTA, Value & Evidence (HV&E) Team Lead , Lung Cancer** & Precision Medicine will report to and support the ... HV&E Therapeutic Area Lead for Oncology. The **HV&E Team Lead ,...cross-functional product teams, ensuring that HV&E members contribute timely, high- quality health economics and outcomes research work to those… more
- BeiGene (Emeryville, CA)
- …service level to internal stakeholders (eg Commercial Marketing, Regulatory , Quality , CMC, Planning and Logistics). . Lead commercial packaging engineering ... packaging line testing, and temperature-controlled shipping system. . With BeiGene Quality , support our Packaging CMO's in commercial launch and after launch… more
- Bristol Myers Squibb (Brisbane, CA)
- …their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Science Lead reports through the Clinical Science function which provides scientific ... assigned area + May serve as a Clinical Trial Lead or Co- Lead as needed + May...+ Author/Review abstracts/publications + Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned… more
- IQVIA (San Francisco, CA)
- …data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. ... data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the… more
- Pfizer (San Francisco, CA)
- **ROLE SUMMARY** The Global Medical Channel Excellence (MCE) Lead will deliver end-to-end medical channel strategy coordination and implementation tracking across ... MCE LTs, and respective Category Teams, the Global MCE Lead will define implementation success and optimized approaches for...+ Direct external vendors and manage budgets, timelines, and quality of deliverables. + Strong track record of written… more
- IQVIA (San Francisco, CA)
- …end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. ... to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide...and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead , Customer Site Manager,… more
- BeiGene (Emeryville, CA)
- **General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international ... regulatory submission and internal document standards. Clinical ...to support the planning and development of fit-for-purpose, high quality strategic documents in the context of the clinical… more