Responsable des affaires réglementaires internationales CMC – produits pharmaceutiques
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
International Regulatory Affairs Manager for a leading pharma company working remotely in Canada, focusing on CMC regulatory affairs. Requires bilingual skills and technical knowledge of regulatory procedures.
Responsibilities:
- Est responsable des activités réglementaires CMC à l'échelle mondiale pour les projets qui lui sont confiés et s'adapte rapidement à l'évolution des événements et des priorités.
- Est chargé de l'élaboration de la stratégie CMC, avec le soutien de la direction, pour les dossiers de soumission CMC destinés à soutenir les activités de gestion du cycle de vie des produits commercialisés, conformément aux normes réglementaires et scientifiques applicables.
- Comprend, interprète et conseille parfois les équipes sur les réglementations, les lignes directrices, les procédures et les politiques relatives à la fabrication et au contrôle des médicaments, afin d'accélérer la soumission, l'examen et l'approbation des demandes CMC mondiales.
- S'assure que tous les aspects réglementaires CMC appropriés pour la mise sur le marché des produits sont en place, afin de garantir la continuité de l'approvisionnement du marché.
- S'assure que les informations soumises dans le cadre des demandes de maintenance du cycle de vie répondent aux exigences régionales, permettant une flexibilité maximale en matière d'approvisionnement, de production et de qualité, avec un minimum de questions imprévues.
Requirements:
- Un diplôme de licence est requis ; un master est fortement apprécié
- Au moins 3 ans d'expérience
- Bilingue anglais/français
- Connaissance des procédures, systèmes et directives réglementaires, ainsi que de la gestion technique du cycle de vie réglementaire
- Connaissance des produits biologiques
- Expérience dans le domaine des affaires réglementaires CMC et de la gestion technique du cycle de vie, de préférence dans le secteur des produits biologiques ou des vaccins ; capacité avérée à gérer les activités réglementaires courantes, etc.
- Expérience dans la rédaction de modifications techniques CMC et des éléments du Module 3
- Expérience en gestion de projet
- Expérience dans les processus de contrôle des changements
- Connaissance des lignes directrices de l'ICH, des dossiers pharmaceutiques et biologiques
- La connaissance de Veeva Vault est également un atout.
Similar Jobs
Contracts Manager – Federal
Contracts Manager at Senture managing federal contracts, ensuring compliance with regulations, and leading contract negotiations. Requires US citizenship and 5+ years of contract management experience.
Clinical Team Manager – Senior
Clinical Trial Manager overseeing CRO clinical activities and Phase I study management for pharmaceutical development. Ensure compliance with GCP guidelines and timely delivery of clinical objectives.
Consulting Manager, MedTech
Consulting Manager leading strategy consulting projects for MedTech clients. Overseeing teams and driving client engagement in the life sciences industry.
Service Delivery Manager – SMB
Service Delivery Manager overseeing B2B service deliveries for SMBs at T-Mobile. Ensuring high-quality outcomes through effective management and communication with internal teams.
Field Manager
Field Manager overseeing a team of technicians to achieve production goals. Responsible for managing operational expenses and providing guidance to technicians.
PMO Manager
PMO Manager leading program governance and project delivery discipline in a fast-growing technology firm. Ensuring initiatives align with strategic priorities and delivering clarity to all stakeholders.
Manager, Government Relations – Western Region
Manager, Government Relations leading engagement in the Western Region for Zillow Group. Building relationships with government leaders and executing regional strategies.
Manager, Government Relations
Manage Government Relations for Zillow, a leading real estate platform in the U.S. Drive initiatives while supporting customer needs and industry improvement.
Strategic Accounts Manager
Strategic Accounts Manager responsible for managing strategic customer relationships and driving revenue growth at Campspot. Collaborating with teams to enhance customer satisfaction and account performance.
Digital Solution Manager
Digital Solution Manager developing innovative solutions for customer needs. Working with interdisciplinary teams and utilizing AI technologies in a fully remote setting.
Senior Service Cost Optimization Manager
Senior Partner Account Manager ensuring cost savings while maintaining partner service quality for social discovery products. Analyzing performance metrics, developing cost reduction strategies, and managing partner relations.
Medicaid Systems Transition Manager
Medicaid Systems Transition Manager enhancing IT operations for government clients by managing Medicaid system upgrades. Collaborating with teams to ensure seamless service integration.
Consumer Engagement Manager
Consumer Engagement Manager creating and communicating incentive plans for sales teams. Engaging, coaching, and incentivizing to drive revenue for health insurance products.
Technical Manager
Techno-Functional Manager leading Data & AI delivery projects at Expleo. Ensuring agile project management and stakeholder coordination for successful execution.
Assistant Manager – Construction
Assistant Manager coordinating between employees and customers in the Elevator service industry, handling daily operations, safety audits, and client communication in Mumbai, India.
Prozessmanager
Prozessmanager at Dedalus improving healthcare processes for better care provision. Central role in clinical processes and stakeholder collaboration in a remote setting across Germany.
Process Manager
Prozessmanager managing clinical processes and stakeholder communication at Dedalus. Focusing on improving healthcare technology and operations for better patient care.
BI Claims Manager, Courier Delivery
Bodily Injury Manager at Reserv supporting claims director and overseeing delivery courier claims. Balancing leadership and individual responsibilities while promoting efficiency and team development.
APD Claims Manager, Courier Delivery
Claims Manager overseeing and providing support in commercial transportation and delivery claims at Reserv. Responsible for operational effectiveness and leveraging technology to drive efficiencies.
Integrations Manager, Contract
Integration Manager managing post-merger integrations for Podean, a global marketing agency. Overseeing integration planning and execution across cross-functional teams.