- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams + Coach and mentor junior… 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 ... to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global … more
- BeiGene (Emeryville, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure ... a scientific discipline with minimum 5+ years of experience in a global CMC regulatory affairs position (with expertise in biologics and deep experience in… 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 and create ... 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
- BeiGene (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... regular updates on study progress in the region to senior management and Global Clinical Study Manager ...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input… more
- BeiGene (Emeryville, CA)
- …and most importantly, share our passionate interest in fighting cancer. As the Senior Manager , Global Commercial Strategy & Operations, sonrotoclax, you will ... efforts. This role requires strong collaboration with the local markets and medical affairs to deliver an integrated launch plan. You will also be accountable for… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Drug Device Combination Product Development Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage ... product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs , to ensure successful project delivery. *… more
- City National Bank (San Francisco, CA)
- **RELATIONSHIP MANAGER SENIOR , TECHNOLOGY** **WHAT IS THE OPPORTUNITY?** Develops and manages relationships with commercial clients in the assigned business ... and closes loan transactions, ensures conformance with Bank policy and regulatory requirements. Exercises sound credit and risk judgement in approving transactions.… more
- Abbott (Alameda, CA)
- …Research & Development (R&D), Engineering, Manufacturing, Operations, Quality Control, and Regulatory Affairs . **What You'll Work On** + Actively engage ... female executives, and scientists. **The Opportunity** As a Section Manager ,QA, you will be at the forefront of ensuring...a plus + Working knowledge of GCP, Clinical and Regulatory Affairs . + Flexibility in daily activities.… more
- Kelly Services (South San Francisco, CA)
- …the preparation of regulatory submissions and documentation, collaborating with regulatory affairs teams as necessary. Continuous Improvement and Process ... **Kelly(R) Science & Clinical** is seeking a Clinical Research Psychometric Rater and Manager for a fulltime, direct hire position with a pharmaceutical client in… more
- Reyes Holdings (San Leandro, CA)
- …Excellent project management skills + Experience working with cross-functional teams + Excellent Regulatory Affairs skills + Expert Regulatory Knowledge ie, ... Manager is the subject matter expert for scientific, regulatory , technical, food safety and/or quality related to Company....risk and meet system goals + Provide information to senior management for decision making during a crisis situation… more
- Abbott (Pleasanton, CA)
- …+ Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... to restore their health and live full lives. The ** Senior Clinical Research Scientist** is a member of the... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. +… more
- Abbott (Alameda, CA)
- …Review Process: Work to operationalize and streamline the Medical, Legal, and Regulatory (MLR) review processes, including building out a team to reduce workload ... Marketing and key functions across Product, Commerce, Legal, Medical Affairs , Procurement, and Finance. + Program Management: Coordinate cross-functional projects,… more
- Vera Therapeutics (Brisbane, CA)
- …relationships and effectively work across functions, including R&D, business development, regulatory , medical affairs , manufacturing, legal, HR, etc. * Hands-on, ... partnership with medical, and portfolio strategy as well as government affairs and patient advocacy. Responsibilities: * Lead the global commercial vision… more
- BeiGene (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs . + Ensures regional and country information in study systems ... regular updates on study progress in the region to senior management and Global Clinical Study Manager ...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. + Provides regional input… more
- AbbVie (South San Francisco, CA)
- …development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions. + Ensures adherence ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.… more
- Elevance Health (Walnut Creek, CA)
- …and tactical issues. + Work collaboratively with other teams, including legal, compliance, regulatory affairs , in supporting the business. + In a complex and ... serve as an Associate General Counsel Sr. to CarelonRx, a pharmacy benefits manager (PBM) owned by Elevance Health. This position will be responsible for serving… more
- Stanford University (Stanford, CA)
- …regulatory requirements, or experience working with an IRB. + Knowledge of regulatory affairs , including FDA regulations, IRB review and approval process, and ... quality, education and business development managers. You will collaborate closely with the senior research manager , CEC, to train staff and ensure we can… more
- Stanford University (Stanford, CA)
- …directly supervises two exempt level employees, the Learning and Development Program Manager and the Custodialand Facility Operations Program Manager . The ... the R&DE emergency response program which includes serving as the primary on-call manager (about two weeks per year) with other R&DE Managers and Assistant… more
- BeiGene (Emeryville, CA)
- …the region and provides regular updates on portfolio progress in the region to senior management and Global Study and Program team as required.** + **Forms high ... for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders. + Provides regional input on global study… more