Senior Regulatory & Start‑Up Specialist

About the role

The Senior Regulatory & Start‑Up Specialist will act as the single point of contact for site activation activities in Argentina, ensuring compliance with local and international regulations, SOPs, and project timelines. The role supports both new site start‑up and ongoing maintenance, collaborating closely with Site Activation Managers, project teams, and external sponsors.

Key responsibilities

• Coordinate site activation tasks, including regulatory submissions, ethics committee presentations, and ANMAT filings.
• Prepare, review, and distribute regulatory documents such as Informed Consent Forms (ICF) and Investigator Packs (IP) to sites and internal teams.
• Maintain accurate records in internal systems, databases, and tracking tools.
• Monitor site performance metrics and provide feedback to management.
• Develop and agree on project plans and timelines, implementing contingency measures when needed.
• Perform quality control of site‑provided documents and ensure adherence to SOPs and work instructions.
• Serve as a liaison between sites, sponsors, and internal stakeholders, addressing regulatory queries and updates.

Required profile

• Bachelor’s degree in life sciences.
• Minimum 3 years of clinical research experience in regulatory functions within Argentina.
• Demonstrated experience with local submissions, ICF customization, and presentations to ethics committees and ANMAT.
• Fluent written and spoken English.
• Ability to work independently and manage multiple site activations simultaneously.

Required skills

• Regulatory submission preparation and review.
• Informed Consent Form (ICF) customization.
• Presentation of regulatory dossiers to ethics committees and regulatory authorities.