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13 days old

Regulatory Affairs Coordinator

Kelly Services
North Chicago, IL 60064
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.

**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 trials notifications etc.

+ Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.

+ Review of and input on documents related to clinical trial submissions managed by other stakeholders such as DSUR, IB, Protocols.

+ Ensure approved company CTA processes are followed within agreed timelines.

+ Monitor key project milestones (actual vs. planned activities and timelines), and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.

+ Support inspection readiness activities when applicable

+ Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.

+ Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory 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/administrative support for the Clinical Trials Regulatory Group

+ Participate in process improvement initiatives within CTRG and cross-functionally.

+ Support SOP reviews and updates when required.

+ Comply with the companys policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.

+ The candidates decisions can impact the deliverables of clinical R&D programs on key geographic areas, including program timelines and quality, affect the companys image and credibility towards regulatory agencies and subsequently impact registration files, marketing authorizations and ultimately market access and sales.



**Experience**




+ At least 1-3 year Regulatory Affairs or R&D experience.

+ Experience working effectively across cultures and in a complex matrix environment

+ Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.

+ 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 Project Management skills, able to manage multiple activities in line with business priorities and study time goals

+ Understands business needs and impact of regulatory issues on these.



**Education**



Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-08 Expires: 2019-12-09

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Regulatory Affairs Coordinator

Kelly Services
North Chicago, IL 60064

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