Regulatory Submissions Specialist
hace 3 días
Regulatory Submissions Specialist (with Portuguese) IQVIA This role will require special working days as National Holidays and weekends. Job Overview As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. You will review, assess, and process safety data and information received from various sources. You will distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members. Essential Functions Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. Ensure compliance with quality, productivity, and delivery standards per project requirements. Track cases as applicable to the project plan. Identify and report quality problems to senior team members. Liaise with different functional team members and health care professionals to address project-related issues. Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes. Qualifications Bachelor's degree in life-sciences (mandatory). Advanced level of English (mandatory). Advanced level of Portuguese (mandatory). 1-2 years of experience in pharmacovigilance activities. Ideal profile will have specific experience in Regulatory Submissions. Good knowledge of medical terminology and applicable safety databases (ARGUS). Strong organizational skills, attention to detail, and ability to work independently and as part of a team. Work Modality 100% home-based. Will require to work some National Holidays. Will require to work alternate weekends. What we offer? Private Medical Insurance. Internet allowance. Employee Assistance Program: free and confidential support available 24/7 for you and your family such as counselling, referrals and work-life resources. Gympass. Additional week of vacations. 100% work from home #J-18808-Ljbffr
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Regulatory Submissions
hace 2 semanas
Buenos Aires, Argentina Hitachi Vantara A tiempo completoA global contract research organization is seeking a Country Approval Specialist to manage regulatory submissions and activate investigative sites. The candidate will provide advice on regulatory strategies and coordinate with internal teams to ensure timely site activation. A Bachelor’s degree and a minimum of 2 years of relevant experience are required....
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Country Regulatory Submissions Specialist
hace 3 semanas
Buenos Aires, Argentina SAP A tiempo completoA global clinical research organization is seeking a Country Approval Specialist based in Buenos Aires, Argentina. This role is essential for coordinating regulatory submissions and ensuring site activation. The successful candidate will need a Bachelor's degree and at least 2 years of relevant experience. Key skills include attention to detail, effective...
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Regulatory Submissions Specialist
hace 6 días
Buenos Aires, Argentina BEON Tech Studio A tiempo completoRegulatory Submissions Specialist (with Portuguese) IQVIA This role will require special working days as National Holidays and weekends. Job Overview As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. Review, assess, and process safety data and information received from various sources....
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Regulatory Submissions Specialist
hace 1 semana
Buenos Aires, Argentina IQVIA A tiempo completoThis role will require special working days as National Holidays and weekends. _ Job Overview - As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. _ Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third...
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Hybrid Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Argentina Medtronic plc A tiempo completoA global medical technology leader is seeking a Regulatory Affairs Specialist in Buenos Aires. This position requires a bachelor's degree in relevant fields and fluency in English, with over two years of regulatory affairs experience. The role involves direct coordination for regulatory submissions, compliance recommendations, and monitoring of regulatory...
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Remote Regulatory
hace 3 semanas
Buenos Aires, Argentina ibos consulting A tiempo completoA global consulting firm is seeking a Regulatory & Start Up Specialist for a home-based role. This position requires a minimum of 2 years of clinical research experience, particularly in submitting procedures to the Ministry of Health in Argentina. The ideal candidate will possess a Health Sciences degree, a strong command of English, and experience with MoH...
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Senior LATAM Regulatory Affairs Specialist
hace 3 semanas
Buenos Aires, Argentina Directa24 A tiempo completoA global healthcare company is searching for a Regulatory Affairs Sr Specialist to consult on documentation for submissions across LATAM markets. The role requires 3-4 years of experience in the regulatory environment and knowledge of LATAM regulations. Applicants should hold a Bachelor’s degree in life sciences. The position involves preparing...
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Regulatory Affairs Specialist – MedTech
hace 2 semanas
Buenos Aires, Argentina Medtronic A tiempo completoA leading medical technology company is seeking a Regulatory Affairs Specialist to oversee coordination for regulatory submissions and ensure compliance in medical devices. Located in Argentina, the position offers a hybrid work model. The ideal candidate requires a Bachelor's degree in a relevant field and must have 2+ years of experience in regulatory...
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Regulatory Publishing Specialist
hace 2 semanas
Buenos Aires, Argentina Syneos Health, Inc. A tiempo completoA global biopharmaceutical solutions organization seeks a Regulatory Publishing Specialist with Veeva experience in Buenos Aires. This mid-level role includes assembler tasks, document publishing, and ensuring compliance with submission standards. Candidates should have strong skills in publishing systems and document quality control. The company values...
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Country Regulatory
hace 2 semanas
Buenos Aires, Argentina BairesDev A tiempo completoA leading global contract research organization is seeking a Country Approval Specialist in Buenos Aires, Argentina. In this role, you will be responsible for coordinating regulatory country submissions for site activation, providing strategic advice to internal clients, and ensuring compliance with local regulations. Candidates must possess a Bachelor’s...