- Gilead Sciences, Inc. (Foster City, CA)
- …6+ years' relevant experience. + For external candidates, 1+ years' experience in regulatory review of promotions for prescription drugs or other biologic ... of pharmaceutical products. + May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion.… more
- Abbott (Alameda, CA)
- …content development and review for compliance before distribution. + Assist in Regulatory Affairs Ad & Promo SOP development and review . + Assist with ... device labeling. + Acts as core team member providing review and analysis of applicable regulatory guidelines...personnel. + May interface directly with FDA and other regulatory agencies. + Supports the product release process… more
- Edwards Lifesciences (Irvine, CA)
- …implement solutions.* Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements ... also recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings,… more
- Coinbase (Sacramento, CA)
- …of regulatory changes * Support tracking of implementation of process /control changes and post-implementation reviews * Provide advice and support on change ... of alert feed sources / keywords * Assist with review of new content providers and horizon scanning workflow.../ processes * Experience building out a legal / regulatory obligations library or exposure to the process… more
- GRAIL (Menlo Park, CA)
- …regulatory strategy development, product validation, audits, promotional material review , on-market product support, and change control processes. This individual ... applicable to GRAIL's business, providing guidance and recommendations. + Review and approve regulatory strategy documents, ...they can participate in the job application or interview process , to perform essential job functions, and to receive… more
- Nestle (Los Angeles, CA)
- …implementation of a regulatory strategy to support new product development. * Conduct regulatory review of projects at each stage gate as deemed necessary to ... proactively with commercial partners and functional departments to develop, review , and analyze the regulatory compliance, scientific...law. Prior to the next step in the recruiting process , we welcome you to inform us confidentially if… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Diploma/GED and 14+ years of relevant industry experience Preferred Qualifications: + Regulatory review of promotional materials for prescription drug and/or ... cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion. + Review of promotional, corporate, and… more
- Abbott (Alameda, CA)
- …on submission strategies. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label development ... policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal...You'll Work On** + Assist in SOP development and review + Provide regulatory input to product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in scope, as teams are working earlier on TPPs and product strategies. . ** Regulatory Operations & Submissions** Oversee the drafting, review , and approval of ... Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and… more
- BeOne Medicines (San Mateo, CA)
- …complaints arise during product lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more