Viewing 1 - 10 of 1,022 jobs
agreed within the global regulatory strategy * Identifies regulatory requirements and provides regulatory guidance, ... This is inclusive of 3 years of regulatory experience or combination of 5 years regulatory and/or related experience. *...
AND RESPONSIBILITIES: Reviews all quality programs for regulatory compliance. Continually reviews the Quality ... in the preparation of 510K submissions. Provides regulatory guidance to all departments, including Product...
of essential document packets for compliance with global regulatory requirements and AbbVie SOPs. Identify, implement ... organization does not meet expectations could include Regulatory agency citation for non-adherence to regulations...
technology transfer, regulatory submission and/or regulatory compliance, quality assurance, and/or alliance management projects. * Knowledge and application of a disciplined project management process (Six Sigma and Project Management...
Regulatory Affairs Associate Responsible for filing necessary applications and handling all government interactions ... Typically reports to a manager or head of a unit/department.
agreed within the global regulatory strategy * Identifies regulatory requirements and provides regulatory guidance, ... This is inclusive of 3 years of regulatory experience or combination of 5 years regulatory and/or related experience...
This is inclusive of 10 years of regulatory experience or combination of 15 years regulatory and/or related experience. ... areas and submissions experience; involved in global regulatory strategies; has led regulatory or cross...
Act in the capacity of project manager/lead for medical writing projects ... Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with depar...
cross-study statistical methodology, interpretations, regulatory submissions and follow up. * Contributes to ... plans, complex study designs, regulatory meetings, submissions and follow up. * Contribute/co-lead to...
* Accountable for ensuring all other regulatory submissions within the non-US Americas" territories are ... This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience...
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