Senior Medical Writer: Regulatory Submissions Lead

IQVIA is seeking a Principal Medical Writer in Paris to develop regulatory documents (IBs, CSRs, submission documents) for global regulatory authorities. You will lead and guide other writers, ensuring rigorous, data-accurate narratives across multiple compounds.Strong organizational and communication skills are essential for coordinating cross-functional...

BIO15PHARMA recherche un Responsable Affaires Réglementaires & Senior Medical Writer pour piloter la stratégie réglementaire internationale et la production documentaire à forte valeur réglementaire.Assurez-vous que toutes les informations de votre candidature sont à jour et en ordre avant de postuler à cette opportunité.Vous coordonnerez les...

PharmaLex France SAS is seeking a Senior Manager, Regulatory AffairsÊtes-vous le bon/la bonne candidat(e) pour cette opportunité ? Découvrez-le en lisant l'aperçu du poste ci-dessous.- Medical Device to lead regulatory development and project delivery for medical devices and drug-device combinations.You will guide teams, interact with clients and health...

A biopharma company in Paris is seeking a Senior Consultant for Device Regulatory Documentation & Compliance. In this role, you will mentor a team, develop regulatory documentation, and ensure compliance for medical devices and combination products. This opportunity is perfect for someone with 5–7 years of experience in the field, a thorough understanding...

Insulet Corporation seeks an experienced Medical Device Vigilance Specialist with deep expertise in French vigilance requirements and direct experience working with French Competent Authorities. The role focuses on ensuring compliance with post-market surveillance and vigilance obligations in France, serving as the country-specific expert.You will lead...

Title: Regulatory Submission Project Manager Company: Ipsen Biopharm Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we...

Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission...

En Carta Diagnostics in Paris is seeking a Senior Regulatory & Clinical Affairs Manager to own regulatory and clinical strategy for IVDR and FDA pathways, guiding products from technical file to market authorization.You will lead cross‑functional teams across biology, engineering and quality, build robust regulatory routes, and ensure timely, compliant...

En Carta Diagnostics is a synthetic biology diagnostic company focused on the development, manufacturing, and commercialization of innovative point-of-need diagnostic devices addressing major unmet medical needs.Our vision: Transforming every smartphone on the planet into a PCR machine, to bring diagnostics for better care, everywhere.Our flagship product,...