- Jazz Pharmaceuticals (Palo Alto, CA)
- …Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and ... of Jazz cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Jazz programs, from research to registration and beyond. The… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC]Strong project management skills and ability to ... that utilizes AWS and TableauThe Associate Director, Clinical Data Innovation will lead a team of professionals that manage, configure, and program on these… more
- J&J Family of Companies (Milpitas, CA)
- …and emerging issues throughout the product lifecycle and develop solutions. * Represents Regulatory Affairs on cross-functional project teams. * Adheres to ... Sr Regulatory Affairs Specialist - 2406185151W **Description**...well-defined and consistent process across JJV. This individual will lead the discussions and cross-functional reviews of the China… more
- Abbott (Alameda, CA)
- …This is an exciting opportunity at Lingo. **What You'll Work On** + Represent Regulatory Affairs on cross functional project teams and provide strategic ... Abbott is a global healthcare leader that helps people live more fully at...future of healthcare. As an individual contributor, the **Senior Regulatory Affairs Specialist** will support product development… more
- Taiho Oncology (Pleasanton, CA)
- …and contractors. Performance Objectives: + Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence ... Sr. Director, Regulatory Affairs Strategy Pleasanton, CA, USA...two high priority late-phase clinical development programs as Global Regulatory Lead (GRL), responsible for leading … more
- BeiGene (San Mateo, CA)
- …This position will have oversight for supporting functional areas such as Regulatory Affairs (CMC, Strategy, Project Management), Quality/Manufacturing, ... of Submission Dossier Managers with strong collaboration with the Regulatory Project Management function. + Provide direction...lead on global programs within R&D and Global Regulatory Affairs , including the ability to … more
- Gilead Sciences, Inc. (Foster City, CA)
- …of professionals, who work with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs . This position will lead a global group that ... with headquarters in Foster City, California. **Sr Director, CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The...members to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical… 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 ... organization by visiting stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Neurovascular division based hybrid… more
- Abbott (Alameda, CA)
- …with our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist,** as part of the Regulatory Affairs ... CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...maintains work schedule. Establishes priorities of given assignments. May lead a departmental project team. + Establishes… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global ... be based in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for strategic and operational … more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** As a Director, Global Regulatory Affairs , Precision Medicine you will develop and execute Precision ... direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee...need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and… more
- Stryker (San Jose, CA)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... organization by visiting stryker.com We are currently seeking a **Senior Regulatory Affairs Specialist, Pharmaceuticals** to join our Endoscopy Division… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... concepts, messaging, and campaigns. + Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. + Lead by providing the motivation ... provide direction, manage activities, and participate in development plans with Regulatory Affairs Staff. + Effectively deploys appropriate management 'standard… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA Business ... leaders to step up, share ideas, listen, learn, and lead . We're welcoming bright, diverse, and imaginative minds; we're...and overall success of the vendor partnerships utilized by Regulatory Affairs . Gilead Sciences is seeking an… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II - APAC** will work out of our ... of issues and product development and support. + Advises project groups on preliminary or fully assessed regulatory...division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution… more
- Abbott (Pleasanton, CA)
- …place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist** **II** will work out of our Pleasanton, ... core team member providing review and analysis of applicable regulatory guidelines and project regulatory ...+ Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager** position is an onsite opportunity ... Abbott is a global healthcare leader that helps people live more fully at...+ May supervise exempt or non-exempt employees + May lead a cross-functional or cross-divisional project team… more
- Taiho Oncology (Pleasanton, CA)
- Director, Regulatory Affairs CMC Pleasanton, CA, USA...well in a team environment and the ability to lead others. + Working knowledge of project ... mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director, ...consultation with Global Executive Director or designee. + Prepare project and/or status reports as assigned. + Ensures that… 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 & ... Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. +… more
