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Regulatory Affairs Officer

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux).

The consultant will support the local Regulatory Affairs team with regulatory submissions, marketing authorisation lifecycle management, labelling activities, and regulatory compliance for pharmaceutical products and medical devices.

Key Responsibilities:

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Head of CMC Data Management

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to lead and shape the Data Management strategy within a global CMC environment. As Head of CMC Data Management, you will drive data governance, lead a team of Data Managers, and prepare CMC data foundations to support future Data Science and Artificial Intelligence initiatives.

Key Responsibilities

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Clinical Trial Assistant

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As a Clinical Trial Assistant, you will support the operational management of international clinical studies and work closely with Clinical Project Managers and CRA teams across multiple countries. You will play a key role in study coordination, documentation management, regulatory support, and clinical operations activities.

Key Responsibilities

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PV Innovation & Transformation Consultant

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The successful candidate will play a key role in driving innovation, optimizing pharmacovigilance processes and improving data governance following the implementation of a new safety database platform. This position requires a strong combination of pharmacovigilance subject matter expertise, project leadership and a consulting mindset, with the ability to bridge business operations, digital technology teams and external solution providers.

Key Responsibilities

Job Skills

pharmacovigilance leadership act automation lean six sigma life sciences cross functional data data process improvement information system regulatory requirement systems business business process agile service provider communication data quality biomedical sciences continuous improvement data integrity bridge pharmaceutical operational translate business transformation timelines problem solve teamwork process optimization collaboration workflows operations digital transformation digital technology stakeholder management innovation system performance process safety monitor progress enthusiasm provider service sciences information adoption translating consulting data governance business operation validate change management requirements regulatory project scope quality management pv transformation manage track
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Medical Affairs Consultant

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for an experienced Medical Affairs Consultant / Therapeutic Area Medical Lead to provide medical leadership. The role focuses on ensuring the continuity of Medical Affairs activities, driving the execution of regional medical strategies and plans and fostering effective collaboration with regional and local medical teams to support ongoing projects and business objectives.

Key Responsibilities

  • Lead and execute Medical Affairs activities within dermatology and/or rheumatology.
  • Support regional medical strategies and operational medical plans across European markets.
  • Collaborate with Medical Heads, Medical Advisors and cross-functional stakeholders.
  • Coordinate scientific activities, including advisory boards, congresses and medical education initiatives.
  • Support evidence generation projects, including Real-World Evidence (RWE) and Non-Interventional Studies (NIS).
  • Engage with external medical experts and key opinion leaders (KOLs).
  • Ensure scientific accuracy, regulatory compliance and alignment with medical governance.
  • Provide operational continuity during temporary staffing gaps.

Job Skills

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Chargé(e) d'affaires réglementaires

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Nous accompagnons nos partenaires des secteurs pharmaceutique, biotechnologique et des sciences de la vie dans le développement et la mise sur le marché de solutions innovantes. Dans le cadre de notre croissance, nous recherchons un(e) Chargé(e) d'Affaires Réglementaires pour intervenir auprès de l'un de nos clients sur des projets stratégiques à forte visibilité.

Missions :

Rattaché(e) aux équipes réglementaires, vous intervenez sur l'ensemble des activités liées au maintien de la conformité réglementaire des produits et des activités.

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Global Clinical Project Manager

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for a Senior Clinical Project Manager to support the operational management of an international clinical trial in pediatric oncology. This role offers the opportunity to work in a highly collaborative environment and contribute to innovative research programs with global impact.

Key Responsibilities

  • Lead and coordinate the operational conduct of international clinical studies.
  • Oversee study timelines, milestones, budget, and quality objectives.
  • Manage relationships with investigational sites, CROs, vendors, and study stakeholders.
  • Ensure compliance with ICH-GCP, regulatory requirements, and study procedures.
  • Monitor study progress, patient recruitment, and site performance.
  • Identify risks and implement mitigation plans to ensure successful study delivery.
  • Coordinate cross-functional teams and facilitate project governance meetings.
  • Contribute to study reporting, inspection readiness, and continuous process improvement.

Requirements

Job Skills

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Ingénieur Projet Protection Incendie H/F

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Dans le cadre d'un programme d'investissements industriels au sein d'un site pharmaceutique majeur à Toulouse, nous recherchons un(e) Ingénieur Projet Protection Incendie pour piloter des projets liés à l'évolution et à la sécurisation des installations de protection incendie.

Intégré(e) au sein des équipes Ingénierie, vous interviendrez sur l'ensemble du cycle de vie des projets, depuis la définition du besoin jusqu'à la mise en service des installations, tout en garantissant le respect des exigences sécurité, qualité, coûts et délais.

Job Skills

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Ingénieur Projet Génie Civil & Construction H/F

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Dans le cadre d'un projet d'extension d'un bâtiment de contrôle qualité au sein d'un site pharmaceutique basé à Toulouse, nous recherchons un(e) Ingénieur Projet Génie Civil & Construction.

Vous interviendrez au sein d'une équipe projet pluridisciplinaire et serez responsable du pilotage des activités de construction, depuis les phases de préparation jusqu'à la réception des travaux, en garantissant l'atteinte des objectifs qualité, sécurité, coûts et délais.

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Chef de Projet Génie Civil Démolition H/F

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous croyons en des solutions innovantes et en un environnement inclusif où collaboration et développement professionnel vont de pair.

Dans le cadre d'un important programme de transformation industrielle sur un site pharmaceutique basé à Toulouse, nous recherchons un(e) Ingénieur Projet Génie Civil Démolition pour piloter les activités de curage, démolition et préparation des infrastructures nécessaires aux futurs projets industriels.

Intégré(e) au sein des équipes Ingénierie, vous serez responsable du pilotage technique, budgétaire et opérationnel des opérations de démolition, en garantissant le respect des exigences sécurité, environnement et qualité.

Missions Principales :

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