Sr. Regulatory Affairs, Study Start Up Specialist

Accountabilities:
The Senior Regulatory Affairs, Study Start Up Specialist will be responsible for managing regulatory submissions and documentation activities while ensuring compliance with country-specific requirements, global standards, and internal procedures. Advise clinical project teams on regulatory requirements, submission strategies, and country-specific compliance expectations. Perform regulatory assessments, identify compliance gaps, document findings, and communicate risks or recommendations to project stakeholders. Prepare, review, adapt, and quality-check regulatory documents according to local requirements, sponsor expectations, and applicable guidelines. Manage submissions to Ethics Committees, Institutional Review Boards, Competent Authorities, and other regulatory bodies across Latin American countries. Review site documentation for accuracy, completeness, and compliance, collaborating with site personnel, project managers, and clinical teams to resolve issues. Compile and maintain regulatory packages, submission trackers, and trial documentation within electronic systems and study management platforms. Support preparation and quality control of Clinical Trial Applications, informed consent forms, regulatory reports, and country-specific documents. Respond to regulatory questions, deficiency letters, and requests from authorities in collaboration with sponsors and study teams. Monitor regulatory timelines, provide accurate status updates, and participate in internal and external project meetings. Conduct document reconciliation, archiving, quality reviews, and audit or inspection preparation activities. Support continuous improvement initiatives by developing procedures, updating workflows, and identifying opportunities for process optimization. Provide guidance, training, and mentorship to junior regulatory team members and contribute regulatory expertise during presentations and business discussions. Requirements: The ideal candidate will bring strong regulatory affairs experience within clinical research, excellent organizational skills, and the ability to manage complex international projects while maintaining high-quality standards. Bachelor’s degree or equivalent experience in a health-related field such as Nursing, Pharmacy, Life Sciences, or another relevant discipline. 3+ years of experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, or CRO industry. Experience managing clinical trial submissions across multiple Latin American countries. Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and global regulatory requirements. Experience preparing, reviewing, and submitting regulatory documentation for clinical studies. Strong understanding of clinical trial processes, regulatory operations, and study start-up activities. Excellent attention to detail with strong documentation, organization, and quality control skills. Ability to manage multiple priorities, meet deadlines, and work independently in a fast-paced environment. Strong analytical thinking, problem-solving abilities, and sound decision-making skills. Excellent written and verbal communication skills, with the ability to collaborate with international teams and external stakeholders. Fluent English communication skills, both written and spoken. Proficiency with computer systems, document management platforms, and standard productivity tools. Ability to maintain confidentiality and handle sensitive clinical and regulatory information. Customer-focused mindset with strong collaboration and teamwork abilities. Benefits: Hybrid work model with flexibility to support work-life balance. Opportunity to contribute to global clinical research programs that help bring innovative treatments to patients. Career development opportunities through mentoring programs, leadership training, and continuous learning initiatives. Access to ongoing education and professional development resources. Opportunity to work with international teams across multiple countries and healthcare markets. Supportive and collaborative work environment focused on innovation and professional growth. Participation in programs that encourage employee well-being and community engagement.

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