We are on the lookout for a capable Principal Regulatory Affairs Specialist Clinical Research field:CTA to join our stellar team at Confidencial in Confidencial, Confidencial.Growing your career as a Full Time Principal Regulatory Affairs Specialist Clinical Research field:CTA is an awesome opportunity to develop productive skills.If you are strong in communication, decision:CTA at Confidencial today**Job Description**:Principal Regulatory Affairs SpecialistWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - Thousands of employees in locations worldwide connected by tenacity and passion for our purpose:To improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life:Aving therapies to patients.If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - And help get life:Changing therapies to patients faster.Currently is seeking a Principal Regulatory Affairs Specialist to join our growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance andregulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as:Reparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as prime interface with the sponsors of assigned projects.The following skills are required to be successful in this position:Experience developing regulatory strategies globallyExperience and knowledge of bid defence meetingsExperience leading global regulatory projectsClient facing experienceJob QualificationWhat the role requires you to have:Bachelors degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and ilities to perform the jobKnowledge of the global clinical trials landscapeProven project management experience, and experience performing effectively in a client facing roleKnowledge, Skills and ilities:Excellent command of the English language written and oral as well as local language where applicableExcellent attention to detail and quality as well as excellent editorial/proofreading skillsExceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departmentsAdvanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesStrong organizational, time management, and planning skills to create and follow timelines, conduct long:Range planning, adapt to changing priorities and handle multiple projectsExcellent negotia
