Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
The regulatory affairs associate (raa) fulfills the role of local regulatory affairs lead (lral) and is responsible for preparing, submitting and following up on initial and amended regulatory agency (ra), central independent ethics committee (iec), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approvalThe raa is responsible for the provision of information relating to local importation and exportation requirementsWhere locally appropriate they
May be responsible to carry out all practical steps to ensure that importation and exportation requirements are met for investigational product (ip) and any other clinical trial supplies needed for the trial within their countryThe raa is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirementsAdditionally the raa will ensure that insurance certificates, country specific informed consent forms and any other patient documentation adheres to country requirementsThe raa may be responsible for activities related to product registration maintenance.
Management of activities associated with obtaining initial, amendment and other central authority approvals i.eRegulatory agency (ra), central independent ethics committee (iec) and any other central authorities for the assigned country/ countries.
Management of central/country level submissions associated with ensuring investigational product (ip) and any other 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.eDiaries, 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 pra 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 date country 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 with relevant legislation and the project-specific contractual agreement.
Any other duties deemed necessary to secure the success of pra’s business.
Support business development opportunities by providing regulatory input on assigned rfps, rfis and bdms.
Job level accountabilities (responsibilities)
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 to the regulatory intelligence consultant team.
May work with gra team members to provide regulatory consulting services.
Provide mentoring and training for the raa 1 position.
Support raa 1 with more complex submissions.
May serve as country consultant.
May liaise with team/other department members to validate country intelligence before liaising with the appropriate
Gra team member to ensure that the information is disseminated appropriately.
May support, prepare and review gmp and product (drug products, medical devices, cosmetics, food, supplement) submissions for product registration and maintenance to regulatory agencies with appropriate oversight, supports labeling (leaflet, primary and secondary packaging) and promotional material activities based on relevant regulations and updates regulatory systems accordingly.
Qualifications
Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional (i.eRegistered nurse) required
Strong knowledge of current ich and local regulatory agency and/or ethics committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
Minimum 2 year prior experience preparing ra submissions and/or central iec submissions
For clinical trial applications preferred.
Strong 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.
Prior experience using computerized information systems required; experience with pc windows, word processing, and electronic spreadsheets
Required.
Cro experience preferred.
With director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
Read, write, and speak fluent english; fluent in host country language.
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’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 programsIn 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 harassmentAll 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.
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