- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- BeOne Medicines (Emeryville, CA)
- **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible for managing a team of NA leaders 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
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Global Strategic Feasibility Lead leads the development of Global Strategic Feasibility proposals together with the regional ... development across global clinical operations (GCO). Good understanding of global , regional, and country landscape and regulatory requirements. Drive… more
- BeOne Medicines (Emeryville, CA)
- …Description:** This position will be responsible for the delivery of high-quality global medical information in support of BeOne hematology products. This role ... encompasses global product specialist responsibilities for the Hematology franchise, contributions...additional product-specific core teams and initiatives. + Apply legal, regulatory , and compliance requirements to all Medical Affairs activities.… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global ...trends and metrics across the development pipeline. The Senior Director will guide and support the timely review of… more
- BeOne Medicines (Emeryville, CA)
- …Description:** The position will report directly to the Executive Director (ED), Global Value, Access & Pricing (GVAP) Lead , Hematology, and will be ... no Company Leadership endorsement for making the first major regulatory filing has occurred. Under the above definition, an...of the job:** **Pipeline Market Access Strategy Development:** + Lead the creation and implementation of global … more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Abbott is a global healthcare leader that helps people live more...Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is… more
- BeOne Medicines (Emeryville, CA)
- …or/and medical device is a plus. * In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics ...individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions… more
- BeOne Medicines (Emeryville, CA)
- …location in United States and on the East Coast **General Description:** The Global Director of Pricing holds responsibility for developing and executing ... are optimized for payer clinical assessments. Within the assigned geographic scope, the Global Director of Pricing manages price bands and oversees gross-to-net… more
- BeOne Medicines (Emeryville, CA)
- …within Medical Affairs and Clinical Development. This role reports into the Senior Director of Global Scientific Communications and Publications in Solid Tumor ... **General** **Description:** The Solid Tumor Oncology Global Scientific Publications and Communications provides publications expertise and insight into the… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature...the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician Lead … more
- BeOne Medicines (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... experience, including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Travel:** Less than 10%… more
- BeOne Medicines (Emeryville, CA)
- …integration across functional areas. + Ensure that all QMS processes comply with applicable global regulatory requirements (eg, FDA, EMA, ISO 9001, ICH Q10). + ... Process Owners, driving organizational alignment, and ensuring that QMS processes meet regulatory requirements and business needs. The Senior Director plays a… more
- BeOne Medicines (Emeryville, CA)
- …CMC, Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in vendor ... The Director of Comparator Purchasing, Clinical Supply Chain is...IRT system functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Internal Audit, plays a vital role in supporting the VP of Internal Audit by spearheading strategic partnerships ... significant risks while ensuring effective governance, risk management, and regulatory compliance. This role requires fostering collaborative relationships, leading… more
- BeOne Medicines (Emeryville, CA)
- …performance trends **Supervisory Responsibilities:** + Be an individual contributor + Build & Lead global Digital Operations Data Analyst(s) team (as needed) + ... **General Description:** The Director of Digital Clinical Operations Data Products Head...global biotech company + **Leadership** : Ability to lead and mentor a team of data professionals, providing… more
- BeOne Medicines (Emeryville, CA)
- …QMS processes, ensuring their effectiveness, integration, and compliance across global operations. + Lead the design, implementation, maintenance, ... **General Description:** Senior Director , Business Process Owner (BPO) for GxP processes,...**Quality Management System (QMS)** will be accountable for the global design, implementation, and continuous improvement of these critical… more
- BeOne Medicines (Emeryville, CA)
- …study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines. + ... **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and… more
- BeOne Medicines (Emeryville, CA)
- …and external stakeholders to address these impacts.** **Partner with Hematology Early Access Lead and Global Commercial Strategy and Operations (GCSO) to support ... **General Description:** **The Director of Strategic Pricing, Hematology will manage all...Market Access Leadership, MA HQ teams, MA field teams, Global Commercial Strategy and Operations (GCSO) and cross-functional stakeholders… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... diversity, working mothers, female executives, and scientists. **The Opportunity** The Director , Business HR provides consulting and functional expertise to a… more