Regulatory Manager / Senior Regulatory Manager

🕒 il y a 16 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Precision For Medicine

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €75 000 000 Private Equity Round en 2015-12

Healthcare • Consulting • Logistics

Precision for Medicine est un leader spécialisé dans l’accompagnement du développement et de la mise sur le marché de thérapies innovantes, notamment en oncologie, dans les maladies rares et les maladies auto-immunes. Grâce à une gamme complète de services — gestion d’essais cliniques, services de laboratoire et collecte de biospécimens — l’entreprise intègre des capacités avancées en biomarqueurs ainsi que des solutions de fabrication pour fluidifier des processus de développement clinique complexes. Sa mission est d’accélérer la recherche et d’apporter aux patients des solutions médicales qui changent la vie, en dépassant les inefficacités traditionnelles souvent observées dans le paysage du développement pharmaceutique.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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