Senior Regulatory

hace 6 días

Ciudad de México IQVIA A tiempo completo

**Regulatory & Start Up Specialist, c**FSP.**Location: Mexico - Full home based**Job Overview**This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.**This includes supporting **site qualification**, site level regulatory green light and site **maintenance/close-outs**.**Essential Functions**- Participate in development of in-house model process documents.- For assigned sites and countries, serve as a primary site contact for end-to-end study activity.- Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.- Utilize systems and tools to track assigned activities and produce reports and metrics as needed.- Oversee essential document collection, tracking & review.- Support the collection of country and site level intelligence- Support Ethics Committee and Regulatory Authority submissions- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.- **Qualifications**- Bachelor’s Degree in Life Science, Business Administration, Finance or related field or work experience equivalent.- Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, **including experience in EC submission in Mexico.**- ICF customization experience- Fluent English: written and oral communication skills- Ability to negotiate complex contract and payment terms.- Goal oriented, self-starter with proven ability to work independently.- Able to proactively identify issues and provide potential solutions for resolution.- Detail oriented.- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.- Good interpersonal skills

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