Senior Regulatory and Start Up Specialist (Argentina)

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we’re hiring our first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina! As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation. The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to: - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA) , Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP - 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 assigned to the study and to Project Manager/Project Team as relevant - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria - Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration - Prepare, review and manage collection of essential documents required for site activation/IMP release - Customize country/site specific Patient Information Sheet and Informed Consent Forms. - Responsible for/facilitates the translation and co-ordination of translations for documents required for submission - Maintain communication with other key functions participating to country start up i. e.