- 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)
- **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:** 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)
- …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
- The Clorox Company (Pleasanton, CA)
- …**Your role at Clorox:** The Associate Director , Global Trade Compliance will ... lead the strategic direction and execution of world-class Global Trade Compliance programs across the enterprise. This role focuses on driving compliance… more
- BeOne Medicines (Emeryville, CA)
- …implementing, and maintaining QMS processes in alignment with organizational goals, regulatory requirements, and industry standards. The Director , QMS Process ... **General Description:** The Director , QMS Process Owner is responsible for overseeing...Global Change Control process to ensure compliance with regulatory , customer, and organizational requirements. + Act as 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)
- **General Description:** BeOne's Global Technology Solutions team is seeking an experienced and strategic technical leader to serve as both the ITSM Lead and ... technology-enabled transformation across the organization by aligning enterprise, regional, global , and functional requirements into a cohesive platform strategy.… 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
- Abbott (Livermore, 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 ... are helping address some of the World's greatest healthcare challenges. The ** Director of Software Product Development** reports to the Divisional Vice President and… 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)
- General Description: The Associate Director of Contract Management Solutions will partner with Legal and Procurement operations to manage the end-to-end contract ... seamlessly integrating technical expertise with business acumen, the Associate Director will drive innovations that transform contract processes, improve operational… more