Senior Regulatory Submissions Lead

🕒 il y a 1 mois

🌐 Espagne, Pays-Bas, +6 autres pays – Distant

🇪🇸 Espagne – Télétravail 🇳🇱 Pays-Bas – Télétravail 🇸🇪 Suède – Télétravail 🇮🇹 Italie – Télétravail 🇭🇺 Hongrie – Télétravail 🇩🇪 Allemagne – Télétravail 🇫🇮 Finlande – Télétravail 🇵🇹 Portugal – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

👻 Score fantôme 22%

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.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Premier Research

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

🧬 Biotechnologie

💰 Venture Round en 2016-10

Healthcare • Consulting • Biotechnology

Premier Research est une organisation de recherche clinique de premier plan, dédiée à soutenir les entreprises biotechnologiques innovantes dans la transformation d'idées révolutionnaires et de sciences de pointe en nouveaux traitements médicaux. Avec des capacités étendues en recherche clinique et développement de produits, Premier Research propose une gamme complète de services, incluant la consultation réglementaire, des études en situation réelle et de phase tardive, ainsi qu'une expertise dans divers domaines thérapeutiques tels que les maladies rares, la thérapie cellulaire et génique, l'oncologie, la dermatologie et la pédiatrie.

Description

• Lead and execute regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle • Develop and manage regulatory and start-up project plans • Coordinate and submit Clinical Trial Applications to applicable regulatory bodies, import/export licenses, and other regulatory applications for complex, multi-region studies • Submit substantial and non-substantial modifications and required trial notifications through Clinical Study Reports • Lead and execute EU interventional clinical study activities in CTIS, including overall regulatory submission strategy and Part I preparation and completion • Act as the primary regulatory and submissions lead for sponsors and project teams • Align timelines, deliverables, submission strategies, document readiness, and regulatory requirements • Identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns and recommend resolutions • Lead regulatory and submission discussions during kick-off meetings and internal/external study calls • Prepare, review, and obtain sponsor approval for core submission documents and country-specific submission packages • Review IMPDs, protocols, Investigator’s Brochures, informed consent forms, investigational product labels, and other regulatory materials for compliance, completeness, quality, and country-specific acceptability • Define Greenlight Package templates and coordinate country/site greenlight packages with Study Start-Up Associates • Support country and site activation strategies with other functional areas • Ensure quality execution, regulatory compliance, process improvement, budget oversight, and contractual obligation monitoring • Serve as a subject matter expert in GMO, MedTech, and other regulatory domains • Coach, mentor, supervise, and train junior staff • Lead departmental improvement initiatives • Contribute to business development through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development

🎯 Exigences

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus) • 8–10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent • Experience managing submissions for complex trials, different IP types, and different phases globally • Experience managing the CTIS system • Excellent knowledge of ICH/GCP regulations and applicable country-specific regulations • Excellent knowledge of FDA Guidance Documents, EU Regulations, ISO 14155 regulations, drug/device development, and start-up procedures • Ability to work accurately and interpret relevant directives and guidelines • Ability to fulfill objectives and complete projects within agreed budgets and timelines • Collaborative team-player abilities and ability to build an effective team • Ability to multitask and work effectively in a fast-paced environment with changing priorities • Excellent organizational and time-management skills; ability to prioritize work to meet deadlines • Accountable, dependable, and strongly committed to quality • Customer-service-focused approach for internal and external work • Available at short notice is encouraged • Set up to work as a freelancer/contractor

🏖️ Avantages

• Flexibility and balance to support life requirements • Growth, skills, and career development opportunities • Freelance/contract engagement for up to 1 year • Full FTE arrangement • Flexible hiring location