FSP Regulatory & StartUp Specialist

Location: Bogota, Colombia

Company

hirify.global provides clinical research services, healthcare intelligence, technology, and data-driven insights for the life sciences and healthcare industries.

What you will do

• Act as the primary contact for investigative sites during study start-up and activation.
• Prepare, review, submit, and track regulatory documentation and site-specific start-up packages.
• Coordinate submissions to Ethics Committees, IRBs, the Ministry of Health, and other local regulatory authorities.
• Manage Informed Consent Forms and other essential regulatory documents throughout the activation process.
• Track approvals and activation milestones, maintain accurate records, and support study timelines.
• Identify start-up risks, conduct quality reviews, and provide country-specific regulatory expertise to global teams.

Requirements

• Bachelor’s degree in Life Sciences or a related healthcare field.
• At least 2 years of clinical research experience focused on regulatory affairs and study start-up activities.
• Experience with Ethics Committee and regulatory submissions, initial regulatory packages, and ICF management.
• Experience communicating and coordinating with health authorities, including the Ministry of Health or local regulatory agencies.
• Strong understanding of GCP, ICH guidelines, and local clinical research regulations.
• Fluent conversational English, spoken and written, is required.

Culture & Benefits

• Work in an international, collaborative clinical research environment.
• Contribute to studies supporting the development of innovative medical treatments.
• Collaborate with global and cross-functional teams.
• Opportunities for professional growth and continued career development.
• Environment focused on inclusion, integrity, and professional excellence.