Regulatory Affairs Specialist

Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas.• As member of the Regulatory Submissions team, you will contribute to at least one of the following activities:• Preparation, compilation and submission of CT /IND, MAA I NOA. Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation• Management and Implementation of label review, translation requirements, fee requirements etc. for regulatory submissions• Input to the Reg Intel function• Readability testing• IMPD / IB Core Doc review, labelling review for CT• May work either as part of Regulatory Submissions team or as part of a regulatory or cross-functional team depending on the size and nature of project• May support business development activities

What you will be doing:

• Input into Preparation, compilation and submission of CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation, medical device documentation , Readability testingInput into label review, translation requirements, fee requirements etcInput to the Regulatory Intelligence functionIMPD I IB Core Doc review, labeling review for clinical trial applicationsCommunicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICONIdentify issues and address them in a timely manner, including preventive actions. Be solution orientated and own the delivery and commitment on behalf of ICON.Responsible for timely and accurate completion of assigned projects and for timely identification of issues or the need for change ordersBe able to liaise and advise clients on the process and timelines, changes to the regulations as required ensuring timely and quality delivery of projects.Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.Maintain an accurate record of the time associated with each activity .Other duties as assigned.

You are:

• G- Bachelor´s Level Degree
• Good English level  translate 
• 2 years of experience ( Arts Regulatory )

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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. https://careers.iconplc.com/reasonable-accommodationsInterested 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.