Senior Regulatory and Start Up Specialist (Mexico)

📋 Description

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to
• Preparation/Support the development of study specific start-up plans, IMP release requirements and

🎯 Requirements

• Bachelors degree in life sciences or related field (ideally in a scientific or healthcare
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)
• Excellent communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and
• Fluency in English and for non-English speaking countries the local language of country where