- Kelly Services (Sunnyvale, CA)
- …we pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** Remote ... Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs Specialist...for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position offers the… more
- J&J Family of Companies (Santa Clara, CA)
- Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery - 2406219399W **Description** Robotics & Digital Solutions, part of ... Johnson & Johnson Medtech Surgery, is recruiting for a ** Senior Regulatory Affairs Program Lead**...new product clearances and approvals. * Prepares and submits regulatory information required to obtain global market… more
- J&J Family of Companies (Santa Clara, CA)
- Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - MedTech Surgery - 2406219400W **Description** Robotics & Digital Solutions, part of the ... Johnson & Johnson Medtech Surgery, is recruiting for a ** Senior Regulatory Affairs Specialist** _....new product clearances and approvals. * Prepares and submits regulatory information required to obtain global market… more
- Stryker (San Jose, CA)
- …We are currently seeking a ** Senior Staff Regulatory ... improvement in functions. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist**...supporting new product development, assessing design changes to determine global regulatory impact, and completing actions to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this individual will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include, but are not limited to the following:** + Under the supervision of a Global Virology Regulatory Affairs liaison, the intern will work with various ... members in the Gilead Foster City team to support regulatory submissions in the United States and potentially other...college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Responsibilities will include, but are not limited to the following:** + Assist the Global Inflammation Regulatory Affairs Liaison team with projects to ... department goals and objectives. + Interns will assist with regulatory submissions and activities, including but not limited to...college + Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and...of current global and regional trends in regulatory affairs and ability to assess the… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC ... organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and...**Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position… more
- Amazon (Sunnyvale, CA)
- …Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem… more
- Stryker (Fremont, CA)
- … Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership. + Ensures strategic alliances with physicians, key ... external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain … more
- Gilead Sciences, Inc. (Foster City, CA)
- …of the PBC USMA strategic and tactical plans in collaboration with the broader US Medical Affairs team and the Global Medical Affairs team. Candidate must be ... areas, including Commercial, Marketing, Clinical Research, Pharmacovigilance and Epidemiology, Public Affairs , Government Affairs , Regulatory , and Legal +… more
- BeiGene (San Mateo, CA)
- The Executive Director, Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross-functional influence and acts as an… more
- BeiGene (San Mateo, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as… more
- Amazon (Sunnyvale, CA)
- …keen judgement when making decisions about cost/benefit, risk, and opportunity. About the team Global Regulatory Affairs team is responsible for enabling and ... of a global broadband communication system. Key job responsibilities The Senior Regulatory Engineer will be responsible for ensuring that Kuiper products… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB** **DESCRIPTION** + ... than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES**… more
- BeiGene (San Mateo, CA)
- …fight cancer and our commitment to serve patients wherever they reside. As the Senior Director, Global Commercial Leader, Lung Cancer Disease Area Strategy (DAS) ... **General Description:** BeiGene, a global oncology company, has produced a robust pipeline...that meets the needs of various Regional stakeholders including Regulatory and Reimbursement bodies around the globe. This role… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the entire product lifecycle with input from Research, Clinical Development, Regulatory Affairs , Quality, Pharmaceutical Development & Manufacturing, Legal and ... US FDA, EMA, PMDA) + Established reputation as a senior leader in the global pharmacovigilance ecosystem...including academic medicine and industry experience in development, medical affairs and/or regulatory affairs . **Gilead… more
- BeiGene (San Mateo, CA)
- …while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the hematology ... coordination with key internal stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who… more
- Abbott (Santa Clara, CA)
- …methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and ... position reports to the Sr. Manager of Clinical Evaluations Global Regulatory Operations. **What You'll Work On**...of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D, Clinical R&D, Sales and… more