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Specialist, Clinical Trial Strategy and Submissions
3 months ago
**Company Description**
**Job Description** 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**
- 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.
**Preferred**:Relevant advanced degree in life sciences is preferred
**Experience**
- 1-2 years Regulatory Affairs or R&D experience preferable.
- Proactive verbal and written communication style at all levels.
- Solution driven style.
- Shows high level of initiative and ability to work independently
- Has excellent communication/presentation skills, written and verbal; fluency in English.
- Strong proven personal development and motivational skills.
- Strong interpersonal, organisational and team working skills.
- Has critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
- Strong Project Management skills, able to manage multiple activities in line with
business priorities and study time goals
**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
