(Z-461) | Regulatory Affairs Manager, Clinical Development

.A Career with PurposeBionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world.We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are.You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.If you are inspired by changing the lives of patients all over the world, we'd love to hear from you.About the Role We are looking for an individual contributor with advanced knowledge acquired from several years of experience within regulatory affairs in a clinical development setting.You will work independently within a team where you will be tasked to prepare and/or review regulatory documents to support clinical trial submissions as well as independently provide regulatory support for more complex projects across the clinical team.What will your job look like? Acts as a Regulatory Advisor on complex clinical trial projects or programsAbility to administratively, technically, and scientifically review core scientific documentation and feedback for gap analysis to customersPrepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirementsAbility to write scientific documents e.G. Investigational Medicinal Product Dossier, Investigator's Brochure, clinical trial justifications with minimum support of senior staffMay strategically plan and oversee global country submissionsInteracts with internal and external clients to provide regulatory guidance and strategic input for clinical development clinical trialsCan provide support on regulatory business development opportunitiesUnderstands the Scope of Work, deliverables and budget for any given project and ensure timelines are met within budgetEnsures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or Bionical Emas)Deliver regulatory training/presentations as requiredPerforms other tasks or assignments, as delegated by Regulatory managementWhat will you need to succeed? Degree in life science-related discipline or professional equivalentPrevious substantial regulatory affairs experience within a clinical settingGood understanding of the regulations (GCP, ICH, EMA, etc