Regulatory Affairs Manager

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.

The Regulatory Affairs Manager is accountable for working with contributing client business lines to lead operational submissions execution for designated for the team. They may operate as regulatory operational Subject Matter Expert for drive submission teams towards the timely delivery of globally compliant submission-ready components.

Provides an interface to Pfizer Regulatory and Global Product Development (GPD) partners within designated the client Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory and Central Ethics submissions to regional partners and selected Health Authorities.

• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Liaise with the client Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and support the client submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May act as local country liaison when required
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Quilifications

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics processes globally
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Advanced English

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.