Regulatory Affairs Specialist

As a Regulatory Affairs Specialist you will be joining the world’ s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.

What you will be doing:

• • • 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 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.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 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 ICON´s business.
    • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.

You are:Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required.

• Experience with regulatory submissions in clinical research (ANVISA DDCM submissions)
• Good knowledge in clinical trials documents and experience with CRF data entry.
• Advanced English is necessary

Why 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 programs. In 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.Our success depends on the knowledge, capabilities and quality of our people. That’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.ICON, including subsidiaries, 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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.