Cmc Global Project Manager

il y a 4 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

  • Cmc Global Project Manager

    il y a 2 semaines

    Paris, France Ipsen Pharma (SAS) Temps plein

    **WHAT -**Summary & Purpose of the Position** All Ipsen’s assets are managed through a fully integrated Asset Team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle. The main mission of the CMC Global Project Manager (GPM) is to work in collaboration with the CMC Lead, the Asset Operations Lead...

  • CMC Global Project Manager

    il y a 2 semaines

    Paris, Île-de-France Ipsen Temps plein

    WHAT - Summary & Purpose Of The PositionAll Ipsen's assets are managed through a fully integrated Asset Team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle.The main mission of the CMC Global Project Manager (GPM) is to work in collaboration with the CMC Lead, the Asset Operations Lead (AOL), and...

  • CMC Global Project Manager

    il y a 2 semaines

    Paris, Île-de-France IPSEN Temps plein

    WHAT - Summary & Purpose of the PositionAll Ipsen's assets are managed through a fully integrated Asset Team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle.The main mission of the CMC Global Project Manager (GPM) is to work in collaboration with the CMC Lead, the Asset Operations Lead (AOL), and...

  • Senior Manager CMC Regulatory

    il y a 1 semaine

    Paris, France Ipsen Group Temps plein

    Cookie Notice**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...

  • Senior Manager CMC Regulatory

    il y a 2 semaines

    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...

  • Senior Manager CMC Regulatory

    il y a 1 semaine

    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...

  • Senior Manager CMC Regulatory

    il y a 1 semaine

    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...

  • Dossier Delivery Regulatory Cmc Project Manager

    il y a 9 heures

    Paris, France ProductLife Group Temps plein

    Responsibilities **Mission**: To manage the tracking, review and approval of RtQ including the management of all documents through the document management system for a small mocule in Oncoloy. Small molecule background desirable. **Activities and responsibilities**: Use existing tracker created for the filing of the dossier of a small mocule in Oncoloy to...

  • Senior Manager, CMC Regulatory Strategy – Biologics

    il y a 1 semaine

    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...

  • Biologics CMC Regulatory Strategy Lead

    il y a 1 semaine

    Paris, France Ipsen Group Temps plein

    A leading biopharmaceutical company seeks a Senior Manager CMC Regulatory to oversee regulatory strategy for biological projects. This position involves coordinating with cross-functional teams, preparing submission dossiers, and ensuring compliance with international regulations. Candidates must have extensive experience in CMC regulatory affairs, a...