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Senior Global Regulatory Affairs Specialist

Employer
ICON Plc
Location
Malaysia, Homeworking
Salary
Competitive
Start date
13 Nov 2023
Closing date
13 Dec 2023

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 Role:

  • Coordination of Central Independent Ethics Committee (Central IEC), Regulatory Agency (RA) and other central or country level authority submissions to ensure contractual timelines are met.
  • Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these.
  • Provide submission strategy to the client along with all requirements and documentation requests to actualize proposed strategy.
  • Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
  • Depending on the scope of the project, create the master IP labels or ensure that Sponsor provided IP labels are in adherence with Annex 13 or applicable regional requirements. Coordination of country level labeling translation.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
  • Perform role of Global Reviewer in the QC process as appropriate.
  • Act as GRA partner to support the Country Consultant and complete review of Country Fact Sheets to timelines for assigned country(s).
  • Take on responsibility for Subject Matter Expert as designated by GRA Management.
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.

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.

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#LI-Malaysia

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