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Senior Global Regulatory Affairs Specialist- Clinical Trial Application

Employer
ICON - EMEA
Location
Portugal
Salary
Competitive
Start date
23 Sep 2022
Closing date
29 Sep 2022

View more

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

This role can be home-based or office-based

Due to ongoing Global expansion, our business is thriving. We are looking for enthusiastic Regulatory Affairs professionals to grow with our business.



The Global Regulatory Affairs Lead (GRAL) is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This includes communicating the status of submissions to the Start-Up Lead (SUL) and working with them to mitigate risks to Sponsor deliverables. Summary of tasks, including but not limited to:

  • Providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions surrounding these topics.
  • Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
  • Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defence Meetings.


To be successful in the role, you will be:

An ambitious regulatory professional with experience of working as Regulatory Lead across multiple regions.

Additional requirements include:
  • An undergraduate degree ideally inscience, or health-related field.
  • Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
  • Expert knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Fluency in written and spoken English.


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.

Are you a current ICON Employee? Please click here to apply: link

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
Telephone
01628 496300
Location
3rd Floor
Marlow International
Marlow
Buckinghamshire
SL7 1YL
United Kingdom
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