Postgraduate degree in Regulatory Affairs preferredMinimum 10+ years of regulatory experience in biotech or pharmaceutical industryPrevious oncology experience highly preferredMinimum of 7 years regulatory experience in drug development and approval process. Key Responsibilities:Develop and implemen...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Regulatory Affairs experience in a pharmaceutical, biotechnology, medical device, or related environment. Master in Regulatory Affairs preferred. Regulatory C...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...
This role, which reports to the company’s Executive Vice President of Regulatory Strategy & Government Affairs, focuses on public and regulatory affairs at the state and local level across our national footprint. This position will work cross-functionally with the compliance, legal, corporate commun...
The Quality and Regulatory Affairs Specialist is responsible for providing quality and regulatory affairs services, including Drug Master File (DMF) updates, GMP requests from Health Authorities, customer product complaint investigations, annual product reviews, and management of Change Control and ...
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. A minimum of years' experience in Regulato...
This role, which reports to the company’s Executive Vice President of Regulatory Strategy & Government Affairs, focuses on public and regulatory affairs at the state and local level across our national footprint. This position will work cross-functionally with the compliance, legal, corporate co...
Come join our Compliance team as the Compliance Analyst and take your career to a level unattainable in a traditional bank environment! The Compliance Analyst is responsible for assisting the Compliance BSA and Risk Department with the overall daily compliance needs of the bank. Conduct regular comp...
A company is looking for an Epic Willow Analyst/Pharmacist for a remote contract/temp role in the USA. ...
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A company is looking for a Regulatory Affairs Associate in Remote, USA. ...
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A company is looking for an Associate Director, Regulatory Affairs. ...
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A company is looking for a Compliance Analyst - Sanctions for a remote position. Key Responsibilities:Conduct analysis of alerted clients and payments for potential Sanctions issuesLeverage systems to fully disposition potential list matchesStay updated on industry news surrounding US and Global San...
A company is looking for a Regulatory Consulting AssociateKey Responsibilities:Prepare plan documents, amendments, resolutions, policies and procedures, SPDs and SMMsPrepare certain IRS/DOL filings and correctionsResearch and consulting support on regulatory/legislative and compliance itemsRequired ...