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Senior Regulatory Affairs Specialist

Employer
ICON - EMEA
Location
Poland
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

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.

The Role

As a Regulatory Affairs Associate your Responsibilities include, but are not limited to:

Summary of accountabilities:

• Liaising with project teams to procure documents required for regulatory submissions

• Management of preparation, review and coordination of Regulatory submissions on a country level

• Act as a key contact on a country level for all submission related activities and provide oversight for assigned projects

• Management of the submission documents country adaptation if requested

• Tracking and reporting of projects` progress through applicable Company systems

• Perform the role of Local Reviewer in the QC process of the submissions as appropriate

• Providing consultancy to the projects teams on any country regulatory specifics if requested

Qualifications:

• University degree in Life Sciences or Pharmacy is a plus

• Knowledge of applicable ICH Guidelines and understanding of the drug development process will be a plus

• Understanding of clinical research area

• Demonstrated ability to multi-task and work effectively in a fast-paced environment

• Strong communication skills and fluency in written and spoken Hungarian and English languages

• Ability to work as a team player, focusing on solving projects issues in team-oriented environment.

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.

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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