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Full-time
Competitive base salary, Performance related incentives, Medical coverage, Dental coverage, Vision coverage, Retirement plans
Posted 1d ago
~40 hrs/week
Responsibilities
The Senior Regulatory Affairs Specialist manages country-level clinical trial regulatory deliverables and ensures all submissions comply with ICON policies and ICH-GCP principles. They also act as a primary point of contact for regulatory authorities like ANVISA and provide strategic input for submission planning.
Requirements
Candidates must have at least 4 years of experience in clinical trial submissions and advanced knowledge of regional regulatory agency requirements. Proficiency in English and the legal right to work in the specified location are mandatory.
Full job description
Regulatory Scientist - Hybrid
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking a Sr.Regulatory Affairs Specialist to join our diverse and dynamic team. As a Sr.Regulatory Affairs Specialist at ICON, you will complete country and/or regional Clinical Trial Regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with sound scientific/technical principles in line with contractual agreement.
Depending upon experience, become involved, when required, staff training/mentoring and contribute to the review of ICON systems and procedures as appropriate
What you will be doing:
• Input to strategic planning of submissions to RA (DDCM and DEEC), and other country-level bodies, including proactive identification and mitigation of risks, as applicable. • Direct interaction with regulatory authorities (mainly ANVISA) and other country-level bodies. • Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation (DDCM and DEEC) according to applicable requirements. • Arrange internal/external review of submission/documentation according to project requirements. • Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered. • Perform translation management according to project requirements. • Collaborate with other roles in-country/region to meet ICON’s deliverables. • Ensure all project-specific training is completed on time, as applicable. • Adhere to study budget and proactively identifies out of scope activities. • Support the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence. • May mentor junior team members. • May contribute to the review of ICON systems and procedures as appropriate.
Your profile:
• 4+ years of experience in clinical trial submissions. • Experience ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles. • Advanced knowledge of country/region Regulatory Agency (RA) and other country-level authority clinical trial requirements, as applicable.
• Read, write and speak fluent English.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
How many Science & Research jobs are open in São Paulo, Brazil right now?
There are currently 426 open science & research positions in São Paulo, Brazil listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in São Paulo, Brazil?
Companies currently hiring include ICON plc, Anton Paar, IQVIA, Zoetis, Thermo Fisher Scientific, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in São Paulo, Brazil?
Yes — 213 of the 426 open science & research positions offer remote or hybrid work (107 remote, 106 hybrid).
How do I apply for Science & Research jobs in São Paulo, Brazil?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.