Regulatory Manager / Senior Regulatory Manager

About the role

<p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Precision for Medicine is not your typical CRO.&nbsp; At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.&nbsp; What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.</span></p> <p style="text-align: center;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">As a Regulatory Manager, you will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.&nbsp;</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Essential functions of the job include but are not limited to:</span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Provides regulatory guidance throughout the clinical development life cycle</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Works within a project team, and where necessary, leads project for the region or globally</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Assist in development of Regulatory Affairs Specialists and other operational area staff, as required</span></li> <li style=

Skills