Senior Regulatory and Start Up Specialist (Argentina)

The role

The Senior Regulatory and Start Up Specialist manages clinical trial submissions to Competent Authorities and Ethics Committees. This role involves document collection, site activation readiness, and supporting budget and contract negotiations.

What you will do

• Deliver site activation readiness within assigned country and sites
• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees
• Interact with CA/EC and handle responses
• Provide regular updates to the Start Up Lead and Project Manager
• Maintain project plans, trackers, and regulatory intelligence tools
• Prepare study specific start-up plans and essential document review criteria
• Partner with site CRAs to ensure alignment and site collaboration
• Prepare, review and manage collection of essential documents
• Customize Patient Information Sheets and Informed Consent Forms
• Facilitate translation and coordination of required documents

Required qualifications

• Bachelors degree in life sciences or related field, 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
• Ability to communicate both verbally and in writing in English proficiently (Professional level)
• Excellent communication and organizational skills
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
• Fluency in English and the local language of the country where position based
• Ability to prioritize workload to meet deadlines

Nice to have

• Relevant regulatory and site start-up experience for the particular country
• Experience using milestone tracking tools/systems
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)
• RAC certification
• Masters in Regulatory Science

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer expanding capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.