Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist (Argentina) to drive regulatory submissiupport development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queriesMay mentor staff on local study start-up regulations, submissions, and internal proceduresMay interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as requiredPerforms other duties as assigned by management
Qualifications
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 experience3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competenciesAbility to communicate both verbally and in writing at the English proficiently (Professional level)
Other Required:
Excellent communication and organizational skills are essentialExperience using computerized information systems, electronic spreadsheets, word processing and electronic mail requiredFluency in English and for non-English speaking countries the local language of country where position basedAbility to prioritize workload to meet deadlines
Preferred:
Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular countryExperience using milestone tracking tools/systemsCan assist junior SU specialists in problem resolutionAdvanced degree in medical or life sciences (MD, PhD,



PharmD)/RAC certification/Masters in Regulatory ScienceKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsAbility to follow task-specific procedures, be attentive to detail and place importance on accuracy of informationExcellent organizational skillsAbility to effectively interact with project team(s) and effectively communicate in English and the local language of the country where locatedAbility to work independently in a fast-paced environment with a sense of urgency to match the paceExcellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuadeFlexible attitude with respect to work assignments and new learningOccasional travel may be required
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📌 Remote Senior Regulatory & Start-Up Specialist - Argentina (Buenos Aires)
🏢 Precision Medicine Group
📍 Buenos Aires