Senior Regulatory and Start Up Specialist, Argentina

• Deliver timely, high-quality site activation readiness for assigned Argentina sites and mitigate risks
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide submission updates to Start Up/Regulatory Leads and project teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Coordinate translations of submission documents
• Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site activation critical-path data, regulatory timelines, contracts, and budget negotiations
• Support study budget negotiations and investigator contract execution
• Maintain knowledge of local clinical trial laws and regulations and share regulatory knowledge internally
• Maintain audit/inspection readiness and file documents in the relevant TMF
• Support Pre-Study Site Visits, feasibility outreach, country start-up summaries, training, mentoring, client updates, and proposal activities as required
• Perform other duties assigned by management

Requirements

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Professional-level English proficiency
• Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based
• Excellent communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail
• Ability to prioritize workload to meet deadlines
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate excellent computer skills
• Ability to work independently in a fast-paced environment
• Occasional travel may be required

Core Competencies

Demonstrates expertise in regulatory submissions, site activation processes, and compliance with local clinical trial laws. Proficient in managing essential documents and maintaining audit readiness while effectively communicating with cross-functional teams.

Highest-signal resume keywords

• Regulatory Submissions
• Site Activation
• Good Clinical Practice/ICH Guidelines
• Project Management
• Professional-Level English Proficiency

ATS Optimization Keywords

Hard Skills

• Clinical Trial Application Preparation
• Regulatory Intelligence Tools
• Essential Document Management
• Budget Negotiation
• IMPACT Release Requirements

Soft Skills

• Excellent Communication Skills
• Organizational Skills
• Ability to Prioritize Workload
• Independence in Fast-Paced Environment

Certifications & Qualifications

• Bachelor's Degree in Life Sciences
• Registered Nurse (RN) or Equivalent

Industry Keywords

• CRO
• Pharmaceutical Industry
• Biotech Industry
• Competent Authorities
• Ethics Committees

Tools & Technologies

• Computerized Information Systems
• Electronic Spreadsheets
• Word Processing
• Electronic Mail