Global Regulatory Lead

Job title:

Global Regulatory Lead

Company:

Ividata Group

Job description

Description du poste et MissionsActivities & responsibilitiesLeadership on Regulatory strategy :

• Understand key features of the product(s) and relevant regulatory trends and competition across major markets (e.g.,guidelines, precedent) needed to assess the out comes of regulatory strategy(ies) throughout the product(s) lifecycle (e.g.,novel evidence generation, accelerated pathways, orphan, legalbasis,…)
• Ensure GRT has assessed current regulatory requirements (e.g., paediatric plans) and regulatory intelligence across major markets to support regulatory strategy needed to deliver the Target Product Profile
• Accountable for ensuring collaboration across internal stakeholders (e.g., Asset Team, GRT) to create and maintain the product'(s) global regulatory strategy aligned with the Regulatory Strategy Document
• Accountable for the overall regulatory strategy (e.g., ODD, registration, LCM) and major Health Authorities interactions (e.g., EMA, FDA, PMDA, CDE) in close collaboration with RRLs/LRA (HA primary point of contact) (exceptionally GRL may be HA contact for US and/or EU)
• Accountable for label development (i.e: Product information) and Company Core Data Sheet (CCDS), in collaboration with Labeling representative(s)
• Responsible, working with submission management and regional leads, for designing regulatory submission plan
• As Core Member of the team(s) representing Global Regulatory Team
• As owner, accountable for the Reference Dossier and oversees updates for line extensions, market expansion and/or variations
• Accountable for consistency and timely delivery of regulatory documentation throughout the life cycle (e.g., CTA/IND documents, core briefing book, slide set, Q&A, PIP/PSP, CTD Modules) to enable submission timelines
• Provides support to RRL/LRA in key markets to facilitate registration procedures
• Provides support to Market Access in key markets for the core value dossier
• Primary point of contact for all internal communications regarding project status on regulatory processes, strategy and delivery
• Interface with external partners (e.g., CDx providers, licensing partners)
• As needed, core member of In-Licensing and Due Diligence teams
• For CTA/IND, ensure that available regulatory documentation satisfies requirements necessary for study implementation (e.g., regulatory toxicology studies)
• Lead regulatory impact assessment in case of new findings (quality, efficacy or safety)

Profil recherché

• Advanced degree in relevant scientific discipline or equivalent experience Master of Sciences M/S, Pharm D, PhD/MD preferred
• Knowledgeable in ICH, FDA and EMA guidelines and requirements
• Fluent in English. Good knowledge of French is an advantage
• Minimum of 5 years’ experience in managing regulatory process and registration aspects of the drug development process. Prior experience as experienced Global Regulatory Lead preferred
• Experience and stages of the product life cycle is a plus. Equivalent experience at a regulatory agency or in a relevant drug development role will also be considered
• Demonstrated ability to successfully prioritize multiple global tasks, projects and objectives within a defined portfolio

Informations utiles

• Localisation Essonne, France – pas de déplacement
• Contrat CDI
• Salaire Non défini
• Niveau de qualification Ingénieur/Cadre/Bac +5
• Expérience 1 à 7 ans, + 7 ans
• Modalités de travail Temps complet
• Fonction Qualité/Hygiène/Sécurité/Environnement, Ingénierie – Chimie/Pharmacie/Bio.
• Secteur Industrie Pharmaceutique/Biotechn./Chimie
• Télétravail Partiel

Qui sommes nous ?Ividata Life Sciences FranceIvidata Life Sciences accompagne les industriels de la santé depuis 2013 sur l’ensemble du territoire français autour de problématiques scientifiques, techniques et opérationnelle. Nos collaborateurs et nos experts interviennent sur les métiers des opérations cliniques, la biométrie & data science, la pharmacovigilance, les affaires réglementaires, l’assurance qualité.Notre ambition ? Challenger l’existant, anticiper demain, et accélérer notre développement tout en étant soucieux de maintenir notre niveau de relation de confiance avec nos consultants et nos clientsNos consultants sont le cœur de notre réussite : nous sommes convaincus que le bien-être de nos équipes est la clé pour garantir le meilleur accompagnement possible auprès de nos clients.Fort de ses 150 experts, Ividata LS propose une approche complète intégrant stratégie, conseil, services et technologie. Ses 3 piliers : excellence, innovation & bien-être.

Expected salary

Location

Essonne

Job date

Thu, 05 Sep 2024 22:08:24 GMT

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