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SENIOR REGULATORY MANAGER – CONSULTANCY

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We are expanding our Regulatory Affairs team in Precision for Medicine and are excited to offer the role of Senior Regulatory Manager – Consultancy to be based remotely. This role will provide regulatory consultancy to our sponsors and stakeholders globally at Precision for Medicine, part of Precision Medicine Group, LLC.The Senior Regulatory Manager (SRM) inputs to strategic regulatory development advice and provides guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The SRM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The SRM maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function and facilitating business development and proposals for this area.Do you have the skills and experience to meet the challenges, responsibilities and rewards that come from working in a high energy, fast-paced environment? If this sounds like you then we welcome your application.You WillA glimpse of what your day-to-day may look like.Provides regulatory guidance throughout the clinical development life cycleCompile, coordinate, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applicationsDevelops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standardsServe as representative of Global Regulatory Affairs at project team meetings with both external and internal customersWorks within a project team, and where necessary, leads project for the region or globallyOversee and coordinate teams of Regulatory Affairs Specialists to achieve submission targets for contracted programsMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.Assist in development of Regulatory Affairs Specialists and other operational area staff, as requiredProvide 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 informationParticipates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approvalProvides ICH GCP guidance, advice and training to internal and external clientsServe as representative of Global Regulatory Affairs at business development meetingsMinimum RequiredQualifications:Bachelors degree, or equivalent experience, ideally in a scientific or healthcare disciplineComputer literacy (MS Office/ Office 365)Fluent in EnglishOther Required7 + years or more relevant regulatory affairs experienceInformed knowledge of all aspects of the drug development process inclusive of regulatory milestonesSpecialized knowledge of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissionsAbility to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategyKnowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studiedKnowledge and expertise with relevant regulations and guidance supporting pharmaceutical developmentAble to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.Availability for domestic and international travel including overnight staysPreferredAdvanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/masters in regulatory sciencesPossesses basic understanding of financial managementAbout UsPrecision Medicine Group, LLC is the leading global provider of precision medicine research services and creative commercialization solutions for life sciences companies. After completing the largest private investment raise of a life sciences services company in 2012, we have rapidly grown through a series of acquisitions and 20%+ annual organic growth to more than 1,500 people in over 25 offices across North America and Europe.Any data provided as a part of this application will be stored in accordance with our Privacy Policy .Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .
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Detalles de la oferta

Empresa
  • Precision For Medicine
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Salario
  • Sin especificar
Fecha de publicación
  • 12/08/2021
Fecha de expiración
  • 27/12/2021
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