Senior Manager CMC Regulatory
il y a 15 heures
Job TitleSenior Manager, CMC Regulatory Strategy BiologicsDivision / FunctionGlobal Regulatory Affairs (GRA)Manager’s Job TitleDirector/Sr Director CMC Regulatory Strategy BiologicsLocationParis, FR & Paddington, UKJob SummaryResponsible for developing and executing CMC regulatory strategy across product lifecycle—from early clinical trials to marketing application, geographic expansion and life‑cycle management. Works with global regulatory leaders, manufacturing sites, and external partners to align strategy, facilitates dossier development, and mentors junior colleagues.Key ResponsibilitiesCMC Regulatory StrategyLead development of CMC regulatory road‑maps and ensure alignment with global strategy.Prepare regional and global CMC dossier components in eCTD format.Conduct gap and risk analysis, propose mitigation pathways, and communicate with regulatory authorities.Provide regulatory advice on product changes and impact assessment.Coordinate site registration, licence and master file interactions.CMC Dossier PreparationCollaborate with Pharma Development, Technical Ops and SMEs to author CTA (IND/IMPD) and MAA modules 1‑3.Write regulatory technical documentation, update CTD sections and manage quality data extraction.Handle response to regulatory questions and maintain submission trackers.CMC Regulatory Expertise & IntelligenceRepresent CMC strategy in project and global teams.Provide guidance on regulatory changes and industry developments.Engage in industry associations to represent company interests.Resources and PerformanceCoach and develop junior regulatory staff.Monitor CMC performance metrics and recommend improvements.CommunicationMaintain relationships with cross‑functional teams and external partners.Coordinate with regulators through meetings and workshops.Behavioural Competencies RequiredApply values and ethics consistently.Align actions with Ipsen’s mission and patient commitments.Identify and resolve contradictory information.Develop alternative scenarios and prioritize impactful decisions.Make risk‑informed decisions and communicate transparently.Create clarity on goals, accountability and timelines.Share best practices and commit to excellence.Knowledge & Experience (Essential)8‑10 years in CMC regulatory environment for biologics.Experience managing CMC regulatory activity worldwide.Experience in R&D and/or life‑cycle management.Expertise in health‑authority interactions and eCTD publishing.Understanding of US, EU and other export country requirements.Strong written, verbal and interpersonal communication skills.Ability to manage multiple priorities in a fast‑paced environment.Analytical and problem‑solving capabilities.Knowledge & Experience (Preferred)Additional biologics regulatory experience.Technical experience in process or analytical development of biologics.Education / Certifications (Essential)Advanced degree in Pharmaceutical, Medical, Biological or Chemical Sciences.Languages (Essential)English – fluent.Languages (Preferred)French – fluent.Seniority LevelNot ApplicableEmployment TypeFull‑timeJob FunctionLegalIndustryPharmaceutical Manufacturing #J-18808-Ljbffr
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