This job has expired

Regulatory Affairs Specialist

Employer
ICON - EMEA
Location
United Kingdom
Salary
Competitive
Start date
24 Sep 2022
Closing date
29 Sep 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
You need to sign in or create an account to save a job.

Job Details

Regulatory Affairs Associate - UK

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

ICON Biotech Solutions Global Regulatory Clinical Services (GRCS) team helps ICON’s clients navigate the intricate regulatory agency and ethics committee approval and life cycle challenges.

As a Regulatory Affairs Associate at ICON Biotech Solutions you would fulfil the Local Regulatory Affairs Lead (LRAL) role. The LRALs provide “on-the-ground” support for gaining clinical trial authorisation from all country-level authorising bodies including the Regulatory Agency and Central Ethics Committee (CECs). The LRALs prepare submissions according to requirements in the local language and facilitate the assessment-including rapid responses-to questions based on their understanding of current country expectations and rate-limiting factors.

Local regulatory affairs leads (LRALs) are leading forces accountable for all country-level approvals.

GRCS have a thriving team culture which is at the heart of its success and the leadership team are committed to developing continuous learning opportunities for all where we challenge you with engaging work and where your experience adds to your professional development.

You are:

To be successful in this role you need to be an effective communicator, have strong organisational skills, a willingness to learn and be able to approach problems with a creative and collaborative mindset.

We are seeking candidates with,
  • An undergraduate degree ideally in science, or health-related field.
  • The ability to absorb new information and have a passion for learning
  • Strong communication skills and fluency in written and spoken English
  • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations would be advantageous but is not essential.


We welcome applications from those wanting to take the first step in a career within Regulatory Affairs!

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.

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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert