- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is ... global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and… more
- Ascendis Pharma (Palo Alto, CA)
- … information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... of the business, from drug development to marketing. The Senior Manager, Regulatory Affairs will...Affairs will be responsible for supporting and developing global regulatory strategies for the oncology pipeline… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist** position is an on-site ... Abbott is a global healthcare leader that helps people live more...Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is… 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)
- …worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing ... regulatory guidance + Evaluates change proposals for global regulatory impact and plans global...process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix… more
- Kelly Services (Sunnyvale, CA)
- …**Workplace:** Hybrid based in Sunnyvale, CA (3 days week/office) **Position Title:** Senior Regulatory Affairs Associate, New Product Development **Pay ... Kelly(R) Science & Clinical is currently recruiting for a Senior Regulatory Specialist for a contract opportunity...**Overview** This position is a 6-month contract with the Regulatory Affairs New Product Development group and… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager** position is an onsite ... Abbott is a global healthcare leader that helps people live more...Vascular Division. The candidate will combine knowledge of scientific, regulatory , and business issues to enable products, including combination… 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)
- … Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned ... organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and...discipline with minimum 5+ years of experience in a global CMC regulatory affairs position… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biliary Cholangitis (PBC). This role is based in Foster City, CA. Reporting to the Senior Director US Medical Affairs (USMA) Liver - PBC, this director role will ... teams to review, update, and provide insight into Medical Affairs slide decks and local and global ...projects. + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to lead… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …US HIV Prevention Strategy Lead and will work directly with the US and Global teams. The Medical Affairs Associate Director, HIV Prevention, will report directly ... teams to review, update, and provide insight into Medical Affairs slide decks and local and global ...trainings + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Writing is a global , dynamic, and diverse team residing within Global Regulatory Affairs . We work collaboratively to advance the strategy ... scope and estimate required review time. Escalates to more senior team members if special document strategy is needed....work experience in the biopharma industry, eg, clinical R&D, regulatory affairs , quality, or other related discipline.… more
- Stanford University (Stanford, CA)
- Director of Academic Affairs & HR Strategies **School of Medicine, Stanford, California, United States** **New** Administration Post Date 5 days ago Requisition # ... at the School of Medicine. The Director for Academic Affairs & HR Strategies will provide strategic direction and...film screening, or listen to a renowned author or global leader speak. * **A caring culture.** We provide… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB DESCRIPTION** + ... more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr… more