AstraZeneca Pharmaceuticals LP
TITLE: Manager, Regulatory Publishing
LOCATION: Gaithersburg, MD
HOURS: 40 hrs FT / 9am- 5pm; Mon-Fri
DUTIES: Manage Clinical and Patient Safety documentation and submission components across each product lifecycle. Responsible for electronic document management, submission compilation and publishing and ensuring regulatory documentation and submissions are compliant with health authority and/or AstraZeneca submission standards. Provide Clinical documentation publishing knowledge to Global Clinical projects, submissions and execution teams and advise on procedural issues, setting submission timelines, processes and Global Regulatory Operations Service Level Agreements. Contribute to planning of complex submission publishing activities such as large submissions with a considerable amount of data and to more than one market. Serve as expert in International Council for Harmonisation and Health Authority standards and requirements.
REQUIREMENTS: Must have a Bachelor's degree or foreign equivalent in Regulatory Affairs, Technology or a related field of study plus three (3) years of experience in offered role, as a Regulatory Affairs Associate or a related role in the IT healthcare or pharmaceutical sector. Employer will accept a Master's degree in a stated field in lieu of Bachelor's. Employer will accept pre or post Master's degree experience. Must possess at least three (3) years of experience within the IT healthcare or pharmaceutical sector with: Driving major drug submission and IT enablement projects across functional project teams; Change Request Management of Regulatory Information Management Systems including analyzing system requirements, reviewing use cases and system test scripts, developing User Acceptance Testing (UAT) and Operational Qualification (OQ) test scripts, managing communication plans and risk logs and supporting post implementation project needs; Developing Regulatory Submission methodologies through analysis of eCTD v4.0, Project Orbis, RTOR, and Brexit; Developing Submission Publishing internal and external training methodologies; Managing regulatory submissions for medical devices and combination products; and Publishing standards for Case Report Forms (CRFs) and engaging with Programming to manage datasets and adjudication packages prior to submission publishing.
Click apply. No calls please. EOE.
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