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Senior Regulatory Affairs Specialist

Employer
ICON - EMEA
Location
Israel, Homeworking
Salary
Competitive
Start date
16 Jan 2023
Closing date
27 Jan 2023

View more

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

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Senior Regulatory Affairs Specialist manages the activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.

Summary of tasks:
  • Management of country level submissions associated with ensuring Investigational Product and any other clinical trial supplies can be imported / exported into/from the country the LRAA is responsible for.
  • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
  • Management of the country level Informed Consent and any other documentation given to patients through to submission and approval by country level RA and Central IEC as appropriate.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
  • Perform role of Local Reviewer in the QC process as appropriate.
  • Providing consultancy to the client on any country specifics issues if requested.

You are:

A quality focused self-starter with ambition to learn and develop.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
  • An undergraduate degree ideally in science, or health-related field.
  • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
  • The ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Strong communication skills and fluency in written and spoken English and local language


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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.

Company

We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

Find Us
Mini-site
ICON - EMEA
Telephone
01628 496300
Location
3rd Floor
Marlow International
Marlow
Buckinghamshire
SL7 1YL
GB
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