Regulatory Affairs Specialist
- Brazil
- Clinical Monitoring
- ICON Strategic Solutions
- Office Based
TA Business Partner
- Icon Strategic Solutions
About the role
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Who we are
Similar jobs at ICON
Salary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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 I
Reference
JR113534
Expiry date
01/01/0001
Author
Justin HovisAuthor
Justin HovisSalary
Location
Italy
Department
Clinical Monitoring
Location
Italy
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109317
Expiry date
01/01/0001
Author
Mattia CarcangiuAuthor
Mattia CarcangiuSalary
Location
Brazil, Sao Paulo
Department
Clinical Monitoring
Location
Sao Paulo
Santiago
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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 I
Reference
JR119773
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Chile, Santiago
Location
Buenos Aires
Santiago
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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 I
Reference
JR118661
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Brazil
Department
Clinical Monitoring
Location
Brazil
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Investigator Payments Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-109424
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz