Regulatory Affairs Manager (Regional Position) - Home-Based, South Korea
As a Regulatory Affairs Manager (Regional), you will join the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
You will partner with one of the world's premier biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines, this company has built 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 responsible for working with company business lines to lead operational submission execution for designated clinical trial applications. They may act as a regulatory operational Subject Matter Expert and drive the submission team towards timely, compliant, and submission-ready components.
Role Responsibilities:
1. Drive global submission management strategy and activities for assigned protocols, managing required activities, standards, and deliverables related to clinical trial application submission development.
2. Lead and attend relevant meetings to advocate realistic timelines, understand project strategy, and assess the impact of submission activities.
3. Support and lead efforts to ensure high-quality, compliant submissions aligned with industry, agency, and regulatory guidelines, policies, and timelines.
4. Coordinate with core teams, SSU, Study Management Team, and relevant suppliers for essential documents and translation processes.
5. Prepare, review, and support submissions to HA/Regional Clinical Trial Application Hub to obtain necessary approvals.
6. Manage translation coordination for core documents required for submission.
7. Oversee compilation of core packages, contributing to clinical trial applications and documentation as needed.
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Qualifications:
* B.S. in pharmacy, life sciences, business, or information technology; relevant professional experience considered.
* Deep understanding and proven execution of RA and ethics processes globally.
* Technical aptitude with ability to learn new software, regulations, and standards quickly.
* This is a regional, home-based position.
What ICON can offer you:
Our success depends on our people. We prioritize building a diverse culture that rewards performance and nurtures talent.
In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
* Annual leave entitlements
* Health insurance options
* Retirement planning
* Global Employee Assistance Program
* Life insurance
* Optional benefits like childcare vouchers, gym discounts, etc.
Visit our careers website for more:
ICON values inclusion and accessibility. We are committed to a workplace free of discrimination and harassment. If you need accommodations during the application process, please contact us via the provided link.
We encourage you to apply even if you don't meet all requirements. You might be exactly what we're looking for
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