- 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 ... regulatory guidance + Evaluates change proposals for global regulatory impact and plans global...process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix… 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 ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be...Affairs will be responsible for supporting and developing global regulatory strategies for the oncology pipeline… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager ** position is an ... Abbott is a global healthcare leader that helps people live more...Vascular Division. The candidate will combine knowledge of scientific, regulatory , and business issues to enable products, including combination… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to ... organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and...discipline with minimum 5+ years of experience in a global CMC regulatory affairs position… more
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at ... close collaboration with regional study start up team and regulatory affairs + Ensures regional and country...execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing… 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 ... 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
- Abbott (Santa Clara, CA)
- …Sciences; Advanced degree(s) in biomedical science, medicine, nursing, clinical/mechanical engineering, regulatory affairs , or related fields + Full professional ... technical/medical/ regulatory writing experience, risk management, biomedical/clinical research, regulatory affairs , clinical/quality/R&D engineering, or other related… more
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required. + Oversees the regional study team at ... close collaboration with regional study start up team and regulatory affairs . + Ensures regional and country...execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing.… more
- Abbott (Pleasanton, CA)
- …+ Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... Clinical Research Scientist** is a member of the Global Clinical Affairs team who provides scientific... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. +… 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 ... business development managers. You will collaborate closely with the senior research manager , CEC, to train staff...you are looking to make a large impact through global -reaching clinical research, we encourage you to apply! **Duties… more