- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and ... and able to have extensive/in-depth interactions with departments outside of regulatory affairs ; ensures timely preparation of Health Authority submissions… more
- Taiho Oncology (Pleasanton, CA)
- Sr. Director , Regulatory Affairs Strategy Pleasanton, CA, USA Req #356 Friday, March 29, 2024 Looking for a chance to make a meaningful difference in the ... Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic definition/direction, and… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology ... Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director , Regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , CMC Regulatory Affairs - Biologics** **KEY RESPONSIBILITIES** ... The Director , CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio.… more
- Ascendis Pharma (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Gilead Sciences, Inc. (Foster City, CA)
- …make a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...will be filled as a Senior Manager or Associate Director , based on candidate experience. **REQUIREMENTS:** We are all… 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Ascendis Pharma (Palo Alto, CA)
- …position will be based in Palo Alto, CA and reports directly to the Senior Director , Regulatory Affairs . Key Responsibilities + Responsible for strategic and ... to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global … more
- Danaher Corporation (Sunnyvale, CA)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Director HR, Regulatory and Clinical ... will be accountable for end-to-end HR leadership for the Regulatory Affairs and Clinical Affairs ...where necessary and coaching / mentoring these roles. The Director HR will need to closely work with members… more
- Gilead Sciences, Inc. (Foster City, CA)
- …life by advancing the care of patients with life-threatening diseases. **Executive Director , Public Affairs , Corporate Reputation** Reporting to the SVP, Public ... safeguarding and promoting Gilead's overall reputation. This role partners with the Public Affairs Leadership Team, the Office of the CEO, Government Affairs &… more
- BeiGene (San Mateo, CA)
- …to BeiGene SOPs, work instructions, and quality standards + Apply legal, regulatory , and compliance requirements to all Medical Affairs activities **Supervisory ... Description:** The candidate with be responsible for creating and maintaining Medical Affairs slide decks. The Medical Writer will collaborate with Medical … more
- Gilead Sciences, Inc. (Foster City, CA)
- … activities preferred + Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs activities is preferred. ... help create possible, together. **Job Description** **Manager, Global Medical Affairs , Oncology/GI/Pipeline** Gilead Sciences is a biopharmaceutical company that… more
- Stanford University (Stanford, CA)
- …actionable steps for faculty actions. The Manager will also collaborate with the Director of Academic Affairs to interpret School and University Academic ... Academic Affairs Manager, CE and Other Teaching Cluster **School...operations for programs or functions that have significant business, regulatory and/or technical challenges requiring subject matter expertise. +… more
- BeiGene (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross-functional influence and acts as an ... **General Description** + The Senior Director , Global Regulatory Lead will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- BeiGene (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate.** **The individual has regulatory affairs departmental and cross-functional influence and acts as ... **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- GRAIL (Menlo Park, CA)
- …oversees ongoing safety risk-benefit assessments and provide support to Quality and Regulatory Affairs organizations + Partner closely and effectively with ... For more information, please visit www.grail.com . The Sr. Director , Medical Safety will lead the development and implementation...+ Connect with respective colleagues in the Clinical, Medical Affairs , Global Regulatory Affairs , and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Medical Affairs Technology and Medical Excellence personnel, Legal and Regulatory personnel and Medical Affairs colleagues to evolve our content ... operating procedures [SOPs], Work practices). Collaborate with therapeutic area Medical Affairs teams, Medical Information, Regulatory , and Legal to ensure… more
- Stanford Health Care (Palo Alto, CA)
- …the various teams, including Infection Prevention, Patient Safety, Quality Improvement, Regulatory Affairs , Quality Management, Quality Analytics, Directors of ... of the Cardiovascular Health Destination Services Line. **A Brief Overview** The Director of Quality provides overall leadership and direction for service line… 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 ... available at www.stryker.com We are currently seeking a **Staff Regulatory Affairs Specialist** to join our **Neurovascular**...the RA Project Manager or RA Department Manager or Director . + Prepares complex submissions to gain approvals for… more