Regulatory and Start Up Specialist (Clinical Research)

Location: Lisbon, Portugal

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Coordinate country-level site activation and start-up activities in accordance with regulations, SOPs, work instructions, and project requirements.
• Act as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
• Prepare, review, distribute, and quality-control regulatory, ethics, informed consent, and investigator package documents.
• Track document approvals, execution, site progress, project timelines, deliverables, and information in internal systems and databases.
• Provide local regulatory expertise, review site performance metrics, and support contingency planning.
• Communicate completion of regulatory and contractual documentation to project stakeholders and sponsors when required.

Requirements

• Bachelor’s degree in life sciences or a related field, plus 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
• Fluency in Portuguese is required.
• Experience with EC/RA submissions and a strong understanding of local regulatory requirements.
• Knowledge of clinical systems, procedures, corporate standards, and the regulated clinical trial environment.
• Ability to apply GCP/ICH and applicable regulatory guidelines.
• Understanding of the drug development process.

Culture & Benefits

• Full-time employment within an FSP setting.
• Work aligned with international clinical research standards and project procedures.
• Collaboration with investigative sites, sponsors, project teams, and cross-functional departments.
• Environment focused on integrity, diversity, inclusion, belonging, and improving patient outcomes.