- Aequor (San Diego, CA)
- US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: He/She will be responsible for representing regulatory function to approve promotional material ... preferred Regulatory Certification (RAC) preferred Minimum 5 years in Regulatory Affairs , including leadership roles Experience: Experience in promotional… more
- Aequor (Newbury Park, CA)
- …in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager is ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- 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
- Takeda Pharmaceuticals (Sacramento, CA)
- …members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose ... - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory... regulatory . + Advanced education or credentialing in regulatory affairs and project management… 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 (Emeryville, 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
- J&J Family of Companies (Irvine, CA)
- Senior Regulatory Affairs Program Lead - 2406184334W **Description** The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector ... within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead for...techniques. * Provide solutions to complex problems. * Provide regulatory guidance to project teams, as applicable.… 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
- AbbVie (Irvine, CA)
- …projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex ... Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory ...strategies and policies. Duties and Responsibilities: + Represents US Regulatory in project teams. Develops US … 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
- Philips (San Diego, CA)
- …and regulations in the Clinical Integration and Insights (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables ... **Principal Regulatory Affairs Specialist, Software (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager, Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to the ... pre-market regulatory leadership to MMS-PA business + Directs premarket regulatory affairs activities which may include interactions between MMS-PA 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
- Actalent (Carlsbad, CA)
- …functional area and project team meetings as required. Skills: MDR, Regulatory affairs , Medical device, Dental, European Medical Device, submissions, ... Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for medical device registration… more
