- Abbott (Santa Clara, CA)
- …Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to ... post-marketing approval requirements. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label… more
- 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 ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- BeOne Medicines (San Mateo, CA)
- …and consistency with approved labeling. **Essential Functions of the Job:** + Performs regulatory review for promotional materials in conformance with local ... regulatory requirements and company policies/standards. + May also perform regulatory review for non-promotional medical, HEOR, and corporate/investor… more
- Abbott (Sylmar, CA)
- …submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders ... and clinical documentation for submission filing + Compile, prepare, review and submit regulatory submission to authorities...filing + Compile, prepare, review and submit regulatory submission to authorities + Monitor impact of changing… more
- Edwards Lifesciences (Irvine, CA)
- …+ Close collaboration with various cross functional teams including Medical, Legal and Regulatory review of Advertising and Promotion, Grant Reviews and Program, ... needs and interests of the patients we serve. The Senior Director, Corporate & Regulatory Counsel role is a blend of subject matter legal expert and strong business… 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 ... * Work proactively with commercial partners and functional departments to develop, review , and analyze the regulatory compliance, scientific accuracy, and… 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 ... Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion. + Review ...in Regulatory Affairs, Advertising and Promotion. + Review of promotional, corporate, and other non-promotional materials to… 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 ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- Edwards Lifesciences (Irvine, CA)
- …also recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, ... for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review ...with regulatory agencies as part of submission review and on-site audit support. (eg, IDE's, PMA's, annual… more
- Abbott (Alameda, CA)
- …on submission strategies. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label development ... requirements. **What You'll Work On** + Assist in SOP development and review + Provide regulatory input to product lifecycle planning + Continue to revisit and… more