Sr. Regulatory Affairs, Study Start Up Specialist

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.