Regulatory Manager / Senior Regulatory Manager

🕒 Setembro 21

🇬🇧 Reino Unido – Remoto (RU)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 13%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures • Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees • Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications • Develop and/or review submission documents to assure compliance with regulatory standards • Represent Global Regulatory Affairs at project team meetings with external and internal customers • Work within project teams and lead regional or global projects when necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated • Assist in developing Regulatory Affairs Specialists and other operational staff • Provide input into regulatory strategy and timeline development for new study opportunities • Assist in establishing company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients • Represent Global Regulatory Affairs at business development meetings

🎯 Requisitos

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level • 7 years Regulatory experience required for the Senior Manager Regulatory level • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialised knowledge of regulatory activities for at least one major region (EU, US) • Knowledge of submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions • Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry • Experience leading Clinical Submissions • Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy • Knowledge of clinical trials methodology, including working knowledge of protocols and indications being studied • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel including overnight stays • Understanding of financial management • Ability to manage multiple and varied tasks in a fast-moving environment • Good record-keeping skills • Ability to work and plan independently and in a team environment • Ability to resolve project-related problems and prioritise workload to meet deadlines with little management support • Ability to communicate effectively in English, verbally and in written form • Proficiency conducting formal presentations to colleagues, investigative staff, and clients

🏖️ Benefícios

• Employees feel appreciated for their contributions • Employee ideas are valued and nurtured • Equal Opportunity Employer • Reasonable accommodation available for the application process

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