- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …MS Word, Excel, PowerPoint, Teams + Project Management experience + Knowledge of global Regulatory Affairs requirements, regulations and standards + ... self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports...a along with associated Software and Accessories on a global basis from a Regulatory Affairs… more
- Abbott (Alameda, CA)
- …This role ensures worldwide compliance with FDA, ISO 13485, EU MDR, and other global regulatory standards. The Director will provide strategic leadership, ... Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory...* Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within the… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …standards. + ** Regulatory Guidance and Frameworks** : Closely work with Regulatory Affairs team to define and own the development of industry-specific ... organizational culture. **Qualifications:** + Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs , or related field (Master's or RAC… more
- Abbott (Pleasanton, CA)
- …Heart Failure. We have an exciting opportunity for a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure ... Division (HFD) as the Global Director of Clinical Insights Development. This...by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Global Medical Affairs (GMA), Government Affairs & Policy, Public Affairs and Regulatory Affairs to drive integrated HIV Prevention strategies + ... of patients with life-threatening illnesses worldwide. In this role, as **Senior** ** Director , Global Value & Access Strategy** , you will be responsible for… more
- Abbott (San Diego, CA)
- …key cross-functional partners such as Quality Assurance, Operations, Marketing and Regulatory Affairs . * Strong technical, negotiating, decision-making and ... Abbott is a global healthcare leader that helps people live more...treatment and management of diseases and other conditions. The Director , AI, Algorithms & Intelligent Architecture is a key… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more