Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate for a leading pharmaceutical company in North Chicago, Illinois. 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.
- 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 company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
- The candidate's decisions can impact the deliverables of clinical R&D programs on key geographic areas, including program timelines and quality, affect the company's image and credibility towards regulatory agencies and subsequently impact registration files, marketing authorizations and ultimately market access and sales.
Skills and Requirements:
- Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
- 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 proven personal development and motivational skills.
- Strong interpersonal, organizational and team working skills.
- Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
- 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
- Understands business needs and impact of regulatory issues on these.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nadine Rucci at (+1) 215-531-5281 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.