Regulatory Specialist for Latin American Market
hace 1 mes
Iqvia Argentina is seeking a highly skilled Regulatory & Start Up Specialist to join their team. This position will be based at home and will cover Argentina and Mexico.
Responsibilities:
- Perform country-level tasks associated with site activation activities in compliance with local and international regulations, SOPs, project requirements, and contractual guidelines.
- Serve as the point of contact for investigative sites, ensuring adherence to standard operating procedures and quality of designated deliverables.
- Prepare site regulatory documents, reviewing them for completeness and accuracy.
- Maintain accurate records in internal systems, databases, and tracking tools.
- Provide local expertise to project teams during initial and ongoing project planning.
Requirements:
- Health Sciences degree or related field.
- +3 years of clinical research experience within the regulatory area.
- Knowledge of ICF, presentations to ethics committees, COFEPRIS/ANMAT, GCP/ICH, and applicable regulatory guidelines.
- Advanced command of English language.
- Good organizational, time management, communication, and interpersonal skills.
Estimated Salary: $60,000 - $80,000 per annum, depending on experience.
About Us: Iqvia is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
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