JR104761
Senior Regulatory Affairs Specialist
Site: São Paulo - Brazil
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.
Overview:
The Regulatory Affairs fulfills the role of Local Regulatory Affairs Lead and is responsible for preparing, submitting
and following up on initial and amended Regulatory Agency , 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 approval. Is responsible for the provision of information relating to local importation and exportation requirements. Where 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 country. The RA is also responsible for providing review of
the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the RA
will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country
requirements. The RA may be responsible for activities related to product registration maintenance.
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 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 RAS 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 PRA systems.
• Perform role of Local Reviewer in the QC process as appropriate.
• Providing consultancy to the client on any country specific 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.
• 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.
• 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:
You will need:
2 years of experience
Degree on any Biosciences Area (Desirable)
Exp. with DDCN preparation for ANVISA
Protocol Submission Preparation
Exp. with preparation with consent terms (Desirable)
Advanced English for Reading / Writing / Speaking
Spanish (Desirable)
Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX
Note: Hybrid Work Model:
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That is 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 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.
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, 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.
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