Regulatory Affairs Manager -Regional

Regulatory Affairs Manager (Regional Position) -  Home-Based, South Korea

As a (Regulatory Affairs Manager- Regional) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

What you will be doing:

This regional/Global clinical trial application submission manager is accountable for working with contributing company business lines to lead operational submission execution for designated clinical trial application. They may operate as regulatory operational Subject Matter Expert and drive submission team towards the timely delivery for global compliant submission-ready components.

Role Responsibilities:

• Drive Global Submission Management strategy and activities for assigned protocol. Partner with study team, with responsibility management of required activities, standards and deliverables associated with clinical trial application submission development
• 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 company core team, SSU and Study Management Team, regarding essential core documents and local documents as needed from relevant supplier lines across both HA and EC Submission and translation processes
• Prepare, review and support company submission to HA/Regional Clinical Trial Application Hub, in order to obtain all necessary authorizations/approval pertaining to the clinical trial conduct
• Responsible for the co-ordination of the translation for core documents required for submission
• Manage the compilation for cord package build, contributing to clinical trial application and authoring document as required

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You are:

• B.S in pharmacy, life sciences, Business of Information Tech (desirable): equivalent relevant professional experience is considered.
• In-depth understanding and proven execution of RA and Central Ethics process globally
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standard
• This is regional position
• Home-based

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.