Regulatory Affairs Specialist
TA Business Partner
About the role
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Regulatory Affairs Specialist
Seoul, Korea
Are you ready to be a part of a
successful study delivery team? ICON’s award-winning study execution
capabilities have led to the approval of 18 of the world’s top 20 best-selling
drugs. Make your experience count for the benefit of patients worldwide. www.iconplc.com
Job Description:
・Participate in regulatory and/or clinical trial project teams as
required
・Plan and track designated project activities including financial
tracking under supervision
・Initiate research and regulatory intelligence in support of designated
regulatory activities, as required, and provide information on regulatory
requirements
・Effectively contribute to all the aspects of allocated projects in
timely manner including tracking (time and resources) , proactive
identification of risks, scope change, financial implications and provision of
solutions for approval by Managers/Directors
・Be able to solve the problems in pro-active and timely manner by
identifying the deficiencies in the existing processes and procedures and
providing the possible solutions
・Work closely with Process/Project Management team to identify process
and procedure improvements and assist in implementation of continuous
improvement measures to ensure department expertise and to meet department goals
・Specific Regulatory Submission team activities include (but are not
limited to)
・Input into Preparation, compilation and submission of CT /IND, MAA I
NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing
documentation, medical device documentation, Readability testing
・Input into label review, translation requirements, fee requirements, etc.
・Input to the Regulatory Intelligence function
・IMPD I IB Core Doc review, labeling review for clinical trial
applications
・Communicate/liaise with clients, regulatory agencies/competent
authorities and/or other regulatory or Functional Experts on designated
regulatory activities as required.
・Peer review, QA and/or checking, as appropriate, of documents prepared
by other professionals within GRA/ICON
・Identify issues and address them in a timely manner, including
preventive actions. Be solution orientated and own the delivery and commitment
on behalf of ICON
・Responsible for timely and accurate completion of assigned projects and
for timely identification of issues or the need for change orders
・Be able to liaise and advise clients on the process and timelines,
changes to the regulations as required ensuring timely and quality delivery of
projects
・Develop and maintain a current awareness of regulatory requirements
through publications, seminars and appropriate training courses as deemed
necessary
・Maintain an accurate record of the time associated with each activity
・Travel (approximately 10%) domestic and/or international
Qualifications:
・ Bachelor’s Degree or higher graduate
degree from the Medical/science background and/or discipline
・ At least 5+ years of professional
experience for preparation of submission package and regulatory submissions for
IND approval with full understanding of IND submission requirements and
activities
・Experience in communicating with MFDS as
the main contact for initial IND, IND amend and notification
・Experience in developing Country Informed
Consent Forms and following up with Legal as needed in accordance with the
protocol.
・Knowledge of local regulatory
requirements/guidelines and global standards, mainly for IND application
・Good interpersonal communication skills
・ Excellent written and spoken English and
fluency in Korean
・Competent computer skills
Benefits of Working in ICON
In
comparison with our competitor’s and pharmaceutical companies, we provide more
flexible and reasonable working platforms for coaching and educating new
comer’s to be highly respected professionals in our industry. ICON also
provides successful candidates with an excellent employment package and
benefits adapted to the current job market. We are more like an extended family
with consideration of staff as individuals allowing a work-life balance.
Additionally, we have cutting edge technology that will allow
you to analyze study specific processes, audit reports, and governance to
quality system checks and ensure compliance.
What’s Next
Following your application, if you have the necessary skills and experience for
this job you will be invited to an initial telephone interview with one of our
dedicated recruiters who will be able to provide you with more details of this
opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a
workplace free of any discrimination or harassment
We care about our people, since they are the key to our success We provide an
open and friendly work environment where we empower people and provide them
with opportunities to develop their long term career
We are an equal opportunity employer and value diversity at our company We do
not discriminate on the basis of race, religion, color, national origin,
gender, sexual orientation, age, marital status, veteran status, or disability
status
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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