Specialist, Clinical Trial Strategy and Submissions
2 weeks ago
Description
The Regulatory Associate is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes. The Regulatory Affairs Associate is responsible for providing operational support as required to the CTS managers / senior managers.
Major Responsibilities
Operational support to CTS Leads for submission preparation and processing of initial CTA applications, amendments, end of trial notifications etc.
Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
Review of and input into documents related to clinical trial submissions managed by other stakeholders such as IB and Protocols.
Monthly review and initial assessment of comparators SmPCs which are used in all AbbVie trials.
Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
Follow company CTA processes
Populate relevant databases, activity trackers and questions database within agreed timelines and compliance/reporting requirements, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for CTA submission and maintenance activities.
Provide technical support on document preparation e.g. Excel spreadsheets, Power point presentations.
Undertake all necessary training in order to achieve compliance with internal/external processes.
Provide operational support for the Clinical Trial Strategy & Submissions team.
Support SOP reviews and updates when required.
Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
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