Senior Regulatory and Start Up Specialist (Mexico)

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico ! 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