
Regulatory Affairs Specialist
Há 5 horas
Regulatory Affairs Specialist - São Paulo
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 on our mission to shape the future of clinical development
We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.
What you will be doing
- Undertaking variable duties based on project requirements, primarily within Pharmaceutical, BiotechNlogy, or Biologics Regulatory Affairs, with potential involvement in related areas.
- Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.
- Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.
- Providing input to the Regulatory Intelligence function and participating in readability testing.
- Reviewing IMPD/IB Core Docs and labeling for clinical trials.
- Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.
- Facilitating business development activities as needed.
**Profile**:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry.
- Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.
- Familiarity with label review, translation requirements, and regulatory intelligence activities.
- Strong attention to detail and excellent communication skills.
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 maximize 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 site
to read more about the benefits ICON offers.
-
Regulatory Affairs Specialist
1 semana atrás
São Paulo, São Paulo, Brasil ICON plc Tempo inteiro R$60.000 - R$120.000 por anoRegulatory Affairs Specialist Post Register - Home based - São PauloICON 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 on our mission to shape the future of clinical developmentWe are currently seeking a...
-
Senior Regulatory Affairs Specialist
1 semana atrás
São Paulo, Brasil Monster Energy Tempo inteiroOverviewSenior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The LifeAs a Sr Specialist in Regulatory Affairs, you will...
-
Senior Regulatory Affairs Specialist
Há 4 dias
São Paulo, Brasil Monster Energy Tempo inteiroOverview Senior Regulatory Affairs Specialist at Monster Energy. The role focuses on registrations and compliance for raw materials and finished products, and collaboration with regulatory leaders and the regional NPD team to support product registrations and labeling in dynamic markets. The Day In The Life As a Sr Specialist in Regulatory Affairs, you will...
-
Regulatory Affairs Specialist
2 semanas atrás
São Paulo, Brasil Smith & Nephew Tempo inteiroRegulatory Affairs Specialist (São Paulo) page is loaded## Regulatory Affairs Specialist (São Paulo)locations: Brazil - office positionstime type: Full timeposted on: Posted Todayjob requisition id: R85152**Life Unlimited.** At Smith+Nephew, we design and manufacture technology that takes the limits off living!**About the role**Imagine a role where...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, Brasil Insight Global Tempo inteiroJob Description: The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO),...
-
Regulatory Affairs Specialist
2 semanas atrás
São Paulo, Brasil Smith+Nephew Tempo inteiroJoin to apply for the Regulatory Affairs Specialist (São Paulo) role at Smith+Nephew Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! About The Role Imagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we’re looking for...
-
Regulatory Affairs Expert
4 semanas atrás
São Paulo, Brasil beBeeRegulatory Tempo inteiro**Senior Regulatory Specialist Job Description** We are seeking a highly skilled and experienced Senior Regulatory Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and guidelines. **Key Responsibilities:** Maintain awareness of regulatory legislation, guidance, and...
-
Regulatory Affairs Project Management Specialist
2 semanas atrás
Sao Paulo, Brasil Johnson & Johnson Tempo inteiro**REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST**: At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...
-
Senior Regulatory Affairs Specialist
1 semana atrás
São Paulo, Brasil Monster Beverage Corporation Tempo inteiroForget about blending in. That's not our style. We're the risk-takers, the trailblazers, the game-changers. We're not perfect, and we don't pretend to be. We're raw, unfiltered, and a bit unconventional. But our drive is unrivaled, just like our athletes. The power is in your hands to define what success looks like and where you want to take your career....
-
Regulatory Affairs Manager
Há 7 dias
São Paulo, Brasil Essity Tempo inteiro**Regulatory Affairs Manager LATAM**: **Trabalhar na Essity não é apenas uma carreira, é uma chance de tornar o mundo um lugar mais saudável, higiênico e seguro. Com inovações impactantes, juntamente com soluções sustentáveis, nos esforçamos para alcançar mais pessoas a cada ano com as soluções necessárias e essenciais para o bem-estar.** **A...