GRA Expert

## GRA ExpertPostuler: Paris: London (UK): Temps complet: Offre publiée aujourd'hui: R-22882Titre :GRA ExpertSociété:Ipsen Innovation (SAS)A propos d'Ipsen:Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.
Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d’Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s’épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.
Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.Description de l'emploi : WHAT
- Summary & Purpose of the Position
• To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.
• Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project.
• To execute the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
• Lead operational excellence initiatives within GRAWHAT
- Main Responsibilities & Technical Competencies
• Overall AccountabilityAccountable for the flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
• Product/Project LeadershipAccountable for the execution of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member:o Implements regulatory strategy for specific projects under supervision of Therapeutic Area Senior Manager/Director/Senior Director.o Contributes to the drafting of the regulatory strategy (Global Regulatory Strategy Document)o Contributes to the data collection supporting building of the regulatory strategy (competitive and regulatory intelligence).o Gathers, evaluates, organizes, manages and collates information for regulatory dossiers relating to development activities e.g. INDs/clinical trial applications, orphan drug designations, PIP/PSP submissions, NDA/MAA e.g. new and extension/variation etco Contributes to review of regulatory dossiers.o Ensures quality authoring of core administrative parts of submissionso Ensures adequate planning.o Coordinates with Global Regulatory Affairs publishing team to ensure appropriate planning, completion of submission request forms, binder creation, publishing and submission (where relevant).o Ensures that regulatory data are adequately reported and QC ed in the relevant tools / databases through data entry team in a timely fashion (eg Vreg) and that regulatory documentations are tracked/archived in dedicated tools / databases (eg eTMF) Uses a variety of specialist computer applications effectively.o Ensures that quality and regulatory standards are met
• Operational excellenceo Supports operational excellence initiatives and diverse transversal projects within GRA.o Contributes to the review of company systems and processes and is actively involved in the implementation of changes.
• Complianceo Operates according to Regulatory and Ipsen SOPs.
• Reportingo Ensures adequate reporting of his/her activities and participates to various meeting.o Supports and voices the regulatory position consistent with the regulatory strategy validated by the management of the regulatory function.
• Ethics and Complianceo Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policiesHOW
- Knowledge & ExperienceKnowledge & Experience (essential):
• First experience in Regulatory Affairs in the pharmace