Regulatory Manager / Senior Regulatory Manager

<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="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Provides ICH GCP guidance, advice and training to internal and external clients</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 business development meetings</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">The ideal candidate will have the following:</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Minimum Required:</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;">Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical Submissions</span><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"></span> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Availability for domestic and international travel including overnight stays</span></li> </ul> <span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"></span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Competencies</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;">Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Understanding of financial management </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Motivates other members of the project team to meet timelines and project goals</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Flexible attitude with respect to work assignments, and new learning</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Resolves project related problems and prioritize workload to meet deadlines with little support from management</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Collects data of consistently high standard</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Communicates effectively in the English language both verbally and in written form</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency</span></li> </ul> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">#LI-OS1 #LI-Remote</span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. 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