Regulatory Manager / Senior Regulatory Manager

🕒 Setembro 21

🇬🇧 Reino Unido – Remoto (RU)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 23%

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 Medicine Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

💼 Consultoria

🏥 Saúde

📦 Logística

💰 $35.200.000 Venture Round em 2021-03

Consulting • Healthcare • Logistics

A Precision Medicine Group é uma equipe global de especialistas dedicada à medicina de precisão, que combina ciências laboratoriais avançadas, informática translacional, assuntos regulatórios, insights de pagadores e comunicações de marketing. A empresa foca em superar desafios de desenvolvimento de produtos e de comercialização para clientes dos setores farmacêutico e de ciências da vida. Seus serviços incluem P&D orientada por biomarcadores, bem como suporte à comercialização para organizações de ciências da vida, do lançamento à maturidade do produto. A Precision Medicine Group opera por meio de duas frentes principais: Precision for Medicine e Precision AQ, especializadas em soluções clínicas e comerciais, respectivamente.

Descrição

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures • Ensure timely preparation of well-organised, quality regulatory submissions compliant with applicable regulations • Coordinate and prepare regulatory documents for Regulatory Authorities and Ethics Committees • Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications • Provide strategic regulatory input as required • Develop and review submission documents for Regulatory Authorities and Ethics Committees • 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; update Regulatory Leadership • 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 • Maintain and execute corporate quality initiatives across Clinical Solutions business units • Keep current with 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 and 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) • Experience with 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 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 • Strong interpersonal skills and ability to contribute to a team environment • Understanding of financial management • Ability to manage multiple and varied tasks in a fast-moving environment and maintain good records • Ability to work and plan independently and in a team environment • Ability to motivate project team members to meet timelines and goals • Ability to resolve project-related problems and prioritize workload with little management support • Ability to communicate effectively in English, verbally and in writing • Proficiency in 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 applicants with disabilities • Privacy and data protection support for applicants

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