Senior Regulatory and Start-Up Specialist (Argentina)

About the role

Precision Medicine Group is expanding its capabilities across Mexico, Brazil, Argentina, Colombia, Chile and Peru and is hiring its first Senior Regulatory and Start-Up Specialist (Senior RSS) in Argentina. You will be a seasoned professional in regulatory and site start-up activities, responsible for delivering site activation readiness in terms of timeliness and quality, and foreseeing and mitigating risks.

Key responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees and other local bodies, following ICH-GCP and local regulations.
• Interact with Competent Authorities and Ethics Committees, handle their responses and keep the Start Up Lead, Regulatory Lead and Project Team informed.
• Maintain project plans, trackers and regulatory intelligence tools, and prepare study-specific start-up plans, IMP release requirements and essential document review criteria.
• Work with the assigned site CRA 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, and coordinate translations of submission documents.
• Act as Subject Matter Expert for in-country colleagues, train less-experienced staff, and mentor them on local regulations, submissions and procedures.
• Support feasibility, site outreach, budget and contract negotiations, and maintain audit/inspection readiness with documents filed according to the TMF plan.
• Support country start-up summaries, process flows, training sessions and client presentations, and occasionally travel.

Required profile

• Bachelor's degree in life sciences or a related field (ideally scientific or healthcare), or Registered Nurse (RN) or equivalent combination of education, training and experience.
• 3.5 years or more as a Regulatory or Start-Up specialist in a CRO or pharma/biotech company, or equivalent experience and competencies.
• Fluent English; for non-English speaking countries, fluency in the local language is required.
• Preferred: country-specific regulatory and start-up experience, advanced degree (MD, PhD, PharmD), RAC certification, Masters in Regulatory Science, or experience with milestone tracking tools.

Required skills

• Good Clinical Practice (ICH-GCP) knowledge and familiarity with local regulatory requirements.
• Use of computerized information systems, electronic spreadsheets, word processing and email.
• Excellent communication, organization and prioritization skills, able to work independently in a fast-paced environment.