GRA Expert

Titre : GRA Expert Société: 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 GRA WHAT -

& Technical Competencies

• Overall Accountability Accountable 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 Leadership Accountable 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 etc o Contributes to review of regulatory dossiers. o Ensures quality authoring of core administrative parts of submissions o 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 excellence o 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.
• Compliance o Operates according to Regulatory and Ipsen SOPs.
• Reporting o 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 Compliance o Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies HOW - Knowledge & Experience Knowledge & Experience (essential):
• First experience in Regulatory Affairs in the pharmaceutical industry or CRO (minimum of 3 years)
• Knowledge of regulatory procedures
• Excellent written and oral communication skills.
• Strong organizational skills.
• Strong interpersonal skills.
• Curiosity.
• Autonomy. Knowledge & Experience (preferred):
• Knowledge of medical device / drug device combination regulations would be a plus. Education / Certifications (essential):
• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences). Language(s) (essential):
• English #LI-MM1 #LI-hybrid Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us
• ». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature.
• Soyons nous-même

The job is published on Ipsen’s website. Open the original posting ↗ to submit your application. Screeningpass does not fill in a form for you.

Start a contact search from this page. Screeningpass suggests up to three people connected to the role. Choose whom to write to, then Screeningpass looks for their professional email and prepares a message. You review it and send it yourself with Gmail. An email address is not always available, and a reply is never guaranteed.

A search costs 1 credit. Your credit is returned if the search fails. Signing up gives you 3 credits, enough for 3 searches.

Screeningpass brings together internships, apprenticeships and jobs published by companies. For a job, Screeningpass finds someone to contact at the company, looks for their professional email and prepares a message using your CV. See how it works in detail.