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Senior Regulatory Affairs Specialist

Employer
ICON - EMEA
Location
Italy, Homeworking
Salary
Competitive
Start date
3 Jan 2023
Closing date
2 Feb 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.

Regulatory Affairs Associate

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 Regulatory Clinical Services 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 Associate (LRAL) role. The LRALs provide “on-the-ground” support for gaining clinical trial authorisation from all country-level authorizing 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 factor

Local regulatory affairs associates (LRALs) are the powerhouses accountable for all the country-level approvals. In Italy a clinical trial authorisation submission is made to AIFA. The LRAL would be responsible for preparing this submission, working through the assessment process to the successful approval.

Regualtory Affairs 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.

Responsibilities:

• Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
• Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
• Maintain a strong customer service management approach with clients.
• Lead project teams and advise departments on regulatory standards issues and strategies
• Develop, write, and implement standards and procedures related to regulatory operations.
• Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
• Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
• Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
• Completing other appropriate duties as assigned by line manager that require similar skills

You are:

To be successful in this role you need to be an effective communicator, have strong organizational 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.

 


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.

#LI-MG2

 

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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