Associate Regulatory Start Up Manager-Poland

Job description

Brief Position Description: The Associate Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client’s expectations. Minimum Qualifications & Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3 years’ experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations. Through knowledge of applicable regulations. Able to manage in a matrix environment. Confident decision-making and problem-solving. Competent working in virtual teams across time zones. Strong presentation, documentation, and people skills. High proficiency in English. Responsibilities: Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan. Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy. Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU man...