Manager, Regulatory Operations

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Manager, Regulatory Operations

Ideally the successful person will be based in our offices in Ireland (Dublin), Poland (Warsaw) or Canada (Burlington). We can however consider a remote based position for the right candidate

Home or office based

ICON's Strategic Regulatory Services department are currently accepting applications from individuals with Regulatory Operations Management experience to join their team.

The successful candidate will work in close collaboration with the Regulatory Operations leadership to implement and coordinate all aspects of regulatory operations technology implementations, as needed to support the growth of the group.

Responsibilities include but are not limited to:

• Responsible for managing, developing, and updating Regulatory Operations infrastructure, in cooperation with IT and Quality groups
• Maintains current knowledge of regulations and guidelines pertaining to electronic regulatory standards (FDA, EMA, Health Canada, ICH, PMDA, CDISC, and others as required)
• Responsible for formatting, compiling, and submitting regulatory submissions in the eCTD format, including submission planning, review, and QC processes
• Lead a Regulatory Operations project team and advise other departments on regulatory standards issues and strategies.
• Liaise with regulatory agencies and standard development bodies (ICH, CDISC, HL7) in regards to new developments in electronic regulatory standards area. Lead implementation of relevant new regulatory standards within the company.
• Maintain a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, software vendors, co-workers, etc.)
• Liaise with country-specific regulatory affairs personnel for international submissions and registrations.
• Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization, as required
• Develop and maintain style guides, templates, and SOPs related to Regulatory Operations processes
• Other duties as assigned

Skills

• 5-8 years in Regulatory Operations with 2 years of previous people management experience
• Successfully managed compilation and filing of IND, NDA/BLA, MAA, and NDS submissions
• Experience with Veeva Vault EDMS, Extedo eCTDmanager, Lorenz docuBridge preferable
• Hands-on experience with software validation requirements and procedures, systems migration, and updates specific to Regulatory Operations platforms
• Proficient in publishing software (Adobe Acrobat, CSC Toolbox), as well as Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
• Regulatory Affairs Certification (RAC) is an asset

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.