Cmc Global Project Manager

il y a 6 jours


Paris, France Ipsen Pharma (SAS) Temps plein

As a **Global CMC Project Manager**, you will play a pivotal role in driving the operational execution of Chemistry, Manufacturing, and Controls (CMC) activities across the drug development lifecycle. Acting as the central hub between cross-functional teams, you will ensure alignment with strategic objectives, facilitate decision-making, and oversee the seamless integration of plans, resources, and timelines. Your leadership will be essential in delivering high-quality, timely, and cost-effective outcomes that support the advancement of Ipsen’s innovative pipeline.

Main responsabilities:
**Global CMC Project Leadership**:

- Act as the central operational lead for CMC, subteams, and Asset Team members.
- Co-develop and maintain the CMC roadmap aligned with asset strategy.
- Foster a high-performance culture and drive alignment toward shared goals.
- Facilitate strategic decision-making and resolve cross-functional challenges with a big-picture mindset.

**Project & Program Management**:

- Build and maintain integrated CMC project plans across functions, highlighting critical paths and interdependencies.
- Align assumptions, risks, and deliverables with the Global Asset Plan.
- Drive execution of CMC milestones, ensuring quality, budget, and timelines are met.
- Lead monthly CMC operational reviews to track progress, flag risks, and adjust plans proactively.

**Risk & Issue Management**:

- Communicate risks effectively to governance bodies and support strategic decision-making.

**Budget & Resource Oversight**:

- Partner with CMC Leads and Finance to manage budgets, forecasts, and resource planning.
- Ensure accurate tracking of actuals and support tax credit documentation.

**Knowledge & Performance Management**:

- Lead lessons-learned sessions and promote continuous improvement.
- Benchmark against industry standards to challenge and refine project strategies.

**Communication & Governance**:

- Define and implement governance and communication strategies.
- Prepare high-impact materials for governance interactions and ensure timely reporting of KPIs and project status.

**Core Competencies**:

- Strong cross-functional leadership and stakeholder engagement.
- Solid understanding of regulatory, compliance, and drug development processes.
- Skilled in planning, risk management, and performance tracking.
- Proficient in project tools and data-driven decision-making.

**#LI-Hybrid



  • Paris, Île-de-France Ipsen Temps plein

    POSITIONJob TitleSenior Manager, CMC Regulatory Strategy BiologicsDivision / FunctionGlobal Regulatory Affairs (GRA)Manager's Job TitleDirector/Sr Director CMC Regulatory Strategy BiologicsIpsen Job ProfileRegulatory CMCLocation:Paris, FR & Paddington, UKWHAT - Summary & Purpose Of The PositionResponsibility for CMC regulatory strategy for the assigned...


  • Paris, Île-de-France IPSEN Temps plein

    POSITIONJob Title:Senior Manager, CMC Regulatory Strategy BiologicsDivision / Function:Global Regulatory Affairs (GRA)Manager's Job Title:Director/Sr Director CMC Regulatory Strategy BiologicsIpsen Job Profile:Regulatory CMCLocation:Paris, FR & Paddington, UKWHAT - Summary & Purpose of the PositionResponsibility for CMC regulatory strategy for the assigned...


  • Paris, France Ipsen Pharma (SAS) Temps plein

    Title: Senior Manager CMC Regulatory Company: Ipsen Innovation (SAS) 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...


  • Paris, France Ipsen Temps plein

    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...

  • Cmc Regulatory Manager

    il y a 16 heures


    Paris, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...


  • Paris, France Ipsen Pharma (SAS) Temps plein

    A global biopharmaceutical company is seeking a Senior Manager for CMC Regulatory Strategy in Paris. The role involves leading CMC regulatory strategy for biological projects and managing regulatory relationships. Ideal candidates will have 8-10 years of CMC regulatory experience, strong analytical skills, and fluency in English and French. This position...

  • Manager, Regulatory Cmc

    il y a 1 semaine


    Paris, France Cellectis Temps plein

    **Job Description**: The Manager or Senior Manager, Regulatory CMC: - Ensures regulatory compliance between the practices of the Cellectis sites, the regulatory files and the regulations in force such as US and EU Regulations, ICH and Pharmacopoeia. - defines and organize the Cellectis Regulatory CMC activities. - Is responsible for the execution of the...

  • Global Project Manager

    il y a 2 semaines


    Paris, Île-de-France ICON plc Temps plein

    Global Project Manager/ Hematology/ Global Pharma/ Home-basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Project...


  • Paris, France Astek Middle East Temps plein

    OverviewRegulatory Affairs CMC Officer – Paris, France (F/M) role at Alsinova, the CRO subsidiary of the Astek Group. Alsinova is currently recruiting a Regulatory Affairs CMC Officer to strengthen its regulatory affairs team and support strategic projects in the pharmaceutical industry.Your MissionWorking closely with our clients in the Life Sciences...


  • Paris, France Ividata Group Temps plein

    Une société spécialisée en réglementaire cherche un expert en CMC pour fournir des conseils stratégiques sur les dispositifs médicaux. Le candidat doit avoir plus de 10 ans d'expérience en réglementation CMC et être capable de collaborer avec des équipes pluridisciplinaires à l'international. Une excellente communication est essentielle. Vous...