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Cargo Therapeutics
San Carlos, CA, United States
Description The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products. They will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. The
Job Source: Cargo TherapeuticsMaze Therapeutics
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: Maze TherapeuticsCargo Therapeutics
San Carlos, CA, United States
Description The Director, Regulatory Affairs will be responsible for providing global regulatory leadership in support of the development, registration, and lifecycle management of CARGO's oncology products. They will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. The
Job Source: Cargo TherapeuticsBioSpace
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: BioSpaceMazetx
South San Francisco, CA, United States
Become a genetic navigator. Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understanding of the genetic drivers of disease. We celebrate a diversity of pers
Job Source: MazetxGilead Sciences, Inc.
Foster City
**For Current Gilead Employees and Contractors:** Please log onto your Internal Career Site (yworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV,
Job Source: Gilead Sciences, Inc.ALX Oncology Inc.
South San Francisco, CA, United States
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more informa
Job Source: ALX Oncology Inc.Bayside Solutions
Santa Clara, CA, United States
Director, CMC Regulatory Affairs Direct Hire Full-Time Role Salary Range: $208,000 - $235,000 per year Location: Redwood City, CA - Hybrid Role Job Summary: The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual mark
Job Source: Bayside SolutionsRedwood City, CA, United States
The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.
Support Product Development & Registration:
Provides strategic input and technical guidance on global regulatory requirements to product development and clinical teams .
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
Evaluates proposed preclinical , clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require subm i ssions .
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans .
Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
Provides knowledge and critical analysis of preapproval inspections , GCP inspections and clinical investigator relationships .
Provides regulatory guidance on strategy for proposed product claims/labeling .
Ensures clinical and nonclinical data are consistent with the regulatory requirements and suppo r t the proposed product cla i ms .
Manages e lectronic and paper registration development.
Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions .
Prepares cross-functional teams for interactions with regulatory authorities i ncluding panel meetings/advisory committees .
Support Post approval/Post market Activities:
Ensures process is in place for review and approval of advertising and promotion to ensure regulatory compliance .
Develops , implements, and manages systems to track required reports , supplemental submissions, and other post marketing commitments .
Reviews and approves required reports , supplemental submissions, and other post marketing commitments to maintain product regist r ations .
Reviews and app r oves change contro l s to determ i ne the level of change and consequent submission requirements .
Develops , implements, and manages appropriate SOPs and systems to track , manage, report, and communicate product - associated event complaints , recalls , market w i thdrawals and vigilance reports .
Adapts post market strategy based on consideration of factors such as HTA , reimbursement , group purchasing pressures , state/provincial/ regional restrictions, and other legislative/regulatory requirements .
Other Responsibilities
Serves as company ' s deputy Person Responsible for Regula t ory Compl i ance (PRRC) .
Participates in Corporate initiat i ves as appropriate .
Supports Quality Policy and Quality System .
Requirements:
Bachelor ' s degree and a min i mum of 12 years of experience i n Regulatory Affairs in the med i cal device industry.
Demonstrated strength in regulatory submissions activities . Class III, PMA experience is strongly desired.
Commercial and post-market experience is required.
Knowledge of international regulatory requiremen ts, EU MDR.
Strong project management skills and e x perience .
Proficient in timely review of technical data and clinical data .
Demonstrated success i n fast-paced start-up , entrepreneurial work environments.
Ability to write clear , concise , and well thought out technical documents .
Strong leadership , organizat i onal , interpersonal sk i lls.
Excellent presentation skills .
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Email Alert for Director, Regulatory Affairs jobs in Redwood City, CA, United States
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