Regulatory Affairs Specialist

Employer
ICON - EMEA
Location
Denmark, Homeworking
Salary
Competitive
Start date
17 Jan 2023
Closing date
16 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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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 position is home-based anywhere across Denmark (candidates based in any of the Nordic countries with knowledge in Danish, Norwegian and/or Swedish will also be considered)

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 Associate (LRAL) role. The LRALs provide “on-the-ground” support for gaining clinical trial authorization 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 Denmark a clinical trial authorization submission is made to local authorities and the LRAL would be responsible for preparing this submission, working through the assessment process to the successful approval from DKMA and the Ethics Committee.

In this role you would give your expertise in writing and adapting the core patient information sheet to Danish requirements and length, give strategic feedback on the submission documentation, timelines and submission strategies. The aim is to minimize the EC/RA questions and lead the projects to approvals of both initial and subsequent amendment submissions all the way until the Clinical study report is submitted. In this process, you are a key team player to get the project approved to start in the assigned country. You would start working with Danish submissions, and thereafter can expand to work in any of the Nordic countries since we work together as a team across the Nordic region.

Regulatory 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. In the Nordics, we are an experienced local team with many team members who have worked long in the industry and the field which opens up for great onboarding and knowledge exchange and learning discussions for your career. The team is known for being considerate team players with strong dedication, quality and compliance and we wish to include you to this team.

Responsibilities:

  • Management of 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 theassigned country/ countries.
  • Management of central/country level submissions associated with ensuring
  • Investigational Product (IP) and anyother clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
  • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
  • Management of the central/country level Informed Consent and any other documentation given to patients i.e.diaries, questionnaires 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 ICON systems.
  • Perform role of Local Reviewer in the QC process as appropriate.
  • Providing consultancy to the client on any country specifics issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
  • Supporting the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to dateCountry Knowledge Repository.
  • Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
  • If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance withrelevant legislation and the project-specific contractual agreement.
  • Any other duties deemed necessary to secure the success of ICON’s business.
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
  • Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country.
  • Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes tothe Regulatory Intelligence Consultant team.
  • May work with GRA team members to provide Regulatory consulting services
  • May serve as Country Consultant.
  • May liaise with team/other department members to validate Country Intelligence before liaising with theappropriate GRA team member to ensure that the information is disseminated appropriately.

 


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 (PhD is a plus)
  • The ability to absorb new information and have a passion for learning
  • Strong communication skills and fluency in written and spoken Danish and English (if knowing more than one of the Nordic languages it is a plus)
  • Good writing skills
  • Prior experience usingcomputerized informationsystems required; experiencewith PC Windows, wordprocessing, and electronicspreadsheets required.
  • Strong knowledge of currentICH and local RegulatoryAgency and Ethics Committee regulations as they relate topharmaceutical, biological,biosimilar, and medical device product development. Knowledge of currentregional guidelines andregulations is preferred, as well as the ability to understand newguidelines and regulations asthey are issued by major regulatory authorities in theregion.

 


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.

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-Remote

#LI-LR1

 

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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