- Gilead Sciences, Inc. (La Verne, CA)
- …+ Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and ... responses are submitted in accordance with regulatory requirements. + Conducts and serves as a lead/coordinator of investigations and corrective and preventative… more
- Abbott (Pleasanton, CA)
- …closely with cross-functional peers in quality, operation, marketing, clinical and regulatory , medical affairs, commercials to define an aligned and predictable NPD ... protected. + Interfaces with appropriate internal and external resources ( regulatory , customers, etc.) to ensure development programs meet regulatory… more
- AbbVie (Irvine, CA)
- …author, edit and review key section of research protocols, reports and regulatory submissions. Responsibilities: + Based on strong medical and scientific experience, ... knowledge of compliance and regulatory requirements, Allergan Aesthetics customers, markets, business operations and...Bachelors degree in the sciences; advanced degree (eg, MS, PhD ) preferred. + Ability to provide input and direction… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents. *May oversee… more
- AbbVie (San Francisco, CA)
- …scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight ... activities with internal stakeholders (ie, commercial, clinical operations, discovery, statistics, regulatory , etc ) as they relate to on-going medical affairs… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop ... and supports the resolution of CAPAs . Partner with Regulatory to ensure labels meet global regulatory ...with MA/ MS or MBA OR 2+ Years with PHD or PharmD We offer you the opportunity to… more
- Ascendis Pharma (Palo Alto, CA)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Cedars-Sinai (Beverly Hills, CA)
- …keep on track with new regulations/compliance policies in clinical and regulatory sciences. **Qualifications** **This role follows a hybrid work schedule; however, ... you must reside in the commutable area.** **Requirements:** + PhD or other higher education equivalent degree in a...environment. + This role requires a strong background in Regulatory Sciences, Regulatory Affairs, and/or Clinical Research,… more
- Abbott (Alameda, CA)
- …principles - Effectively presents statistical concepts and arguments to management, regulatory agencies and scientists - Provides meaningful and timely input in ... a project leader on key initiatives PROJECT COORDINATION AND REGULATORY ACTIVITIES - Coordinates and leads the work of...MS/MA with 5+ years of related work experience or PhD with 3+ years of related work experience preferred… more
- BeOne Medicines (San Mateo, CA)
- …across the product lifecycle - from early research and development, regulatory engagement, commercialization, access and throughout the product lifecycle to ensure ... ground up, fostering deep engagement with patient advocacy communities, navigating regulatory / compliance frameworks and demonstrating expertise in clinical trials,… more