Global Submission Project Manager

il y a 1 jour

Anderlecht, Belgique UCB S.A. Temps plein

**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

The **Global Submission Project Manager** role is leader driving projects forward through the translation of regulatory strategy to executable plans and coordination of cross-functional team efforts. He/she will utilize in-depth knowledge of global regulatory submission requirements, eCTD structure/format and associated planning software (Planisware) to create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines. He/she ensure teams meet target submission dates and proactively focus on critical path acceleration.

Operationally, the Global Submission Project Manager will be focused on driving the submission team’s alignment with the Project plan, including meeting identified targets/actions, assessment of resource estimates and utilization, and adherence to agreed timelines. The Global Submission Project Manager acts as champion for Project Management techniques and processes, coaches team members in these areas and shares lessons learned for continuous improvement.

As a **Global Submission Project Manager**, you will have the following responsibilities:

- Support to Submission Team for the project management of major submissions
- Assessing the specific team’s needs and potential gaps and providing targeted project management solutions as applicable.
- Through cross functional collaboration, creates and maintains a Global Submission Plan that captures detailed list of eCTD content and associated key activities for content delivery
- Work with Functional teams to identify ways to optimize and accelerate bringing products to market, focusing on submission activities and processes
Leads submission planning discussions / Submission Meeting Management incl. setting agendas, minutes and follow up on key actions with stakeholders
- Ensure team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities
- Identify any issues, risks, or impact due to changes in strategy and/or timelines throughout the submission process.
- Performs scenario planning when multiple regulatory strategies are being considered - ensuring flexible and agile use of resources and funding.
- Create visuals, reports, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
- Translate Post submissions requirement into an executable post-submission plan
- Identify key learnings and best practices which are then used to refine and improve submission processes.
- Drive process improvements and embed best practices across programs
- If required, support resource and cost planning across the asset portfolio
- Identify internal team synergies and/or conflicts early and propose solutions in agreement with stakeholders
- Representation of the project at “Governance” (e.g., PVU or GRA Leadership Teams), when requested.
- Contribute to the continued development of a consistent UCB Project Management community that aligns on process and best practices
**About you**

You should have:

- Bachelor’s Degree in a science or business-related field is required
- 3+ years’ experience as a project manager leading complex projects in a multi-disciplinary, global environment is required
- Experience in Regulatory Affairs or Clinical Development preferred (not required)
- Advanced expertise with project management related software and tools (i.e. MS Project, SharePoint etc). Advanced expertise in Planisware would be a strong plus.
- Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related Communication Skills - Demonstrated ability to clearly communicate/ prepare presentations for management.
- Leadership Skills - can lead and motivate team members, without direct line management responsibility.
**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want

  • Global Submission Lead Cmc

    Il y a 4 mois

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Global Submission Lead CMC & Devices** to join us in our **Regulatory Excellence** team, based in our Brussels (Belgium) or Slough (UK) offices **About the role** The primary purpose of the Global Submission Lead CMC & Devices is to bring project management solutions to the Global Regulatory Affairs...

  • Regulatory Submission Manager

    il y a 3 semaines

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Regulatory Submission Manager** to join us in our **Business Submissions & Operations (Regulatory Operations)** team, based in any of our Brussels (Belgium), Monheim (Germany) or Slough (UK) offices. **About the role** The Dossier Manager plays a critical role in streamlining and facilitating...

  • Global Regulatory Project Management Team Lead Hq

    Il y a 7 mois

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Global Regulatory Project Management Lead** to join us in our **Global Regulatory** team, based in any of our Brussels (Belgium), Slough (UK), Raleigh or Atlanta (US) sites. **About the role** The Global Regulatory Project Management Lead is responsible for the global Regulatory Project Management...

  • Global Regulatory Cmc Scientist

    il y a 1 semaine

    Anderlecht, Belgique UCB S.A. Temps plein

    **Make your mark for patients.** We’re here because we want to build the future and transform patients’ lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care...

  • Global Regulatory Lead

    Il y a 7 mois

    Anderlecht, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Global Regulatory Affairs Lead** who is **Strategic, collaborative, and dynamic** to join us in our **Global Regulatory Affairs** team, based in our sites either in **UK, Germany, Belgium, or US.** **About the role** You will play a pivotal role in leading and providing regulatory leadership to an...

  • Atcon Global

    il y a 1 mois

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job The IT Web Project Manager will support the Patient Impact department Omnichannel strategy by managing the correct implementation of commercial technology projects aimed at health care professionals (HCP's) and patients. Her/His role will be critical to offer HCP's and patients access to the right information...

  • Atcon Global

    Il y a 2 mois

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job The IT Web Project Manager will support the Patient Impact department Omnichannel strategy by managing the correct implementation of commercial technology projects aimed at health care professionals (HCP's) and patients. Her/His role will be critical to offer HCP's and patients access to the right...

  • Regulatory Cmc

    il y a 3 jours

    Anderlecht, Belgique UCB S.A. Temps plein

    **Make your mark for patients** We are looking for a **Regulatory CMC & Devices Project Manager** to join us in our **Global Regulatory** team, based in any of our **Brussels** (Belgium), **Raleigh** or **Atlanta** (US) or **Toronto** (Canada) offices. The primary purpose of the Global Regulatory CMC & Devices Project Manager (PM) is to bring project...

  • Project Manager

    il y a 1 jour

    Anderlecht, Brussels, Belgique Atcon Global Temps plein

    Context of the mission/Objective(s) of the job As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities As a Project Manager you will have a strong focus on the BUILD activities, which means that you willAct as the primary contact point towards the Business Product...

  • Project Manager

    il y a 5 jours

    Anderlecht, Brussels, Belgique Atcon Global Temps plein

    Location: AnderlechtLanguages: English and Dutch and/or FrenchEmployment Type: FreelanceStart Date: ASAPEnd Date: 31/12/2025 Context of the mission/Objective(s) of the job:As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities.As a Project Manager you will have a...

  • Project Manager

    il y a 4 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/Objective(s) of the job As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities As a Project Manager you will have a strong focus on the BUILD activities, which means that you will Act as the primary contact point towards...

  • Project Manager

    il y a 5 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Location: Anderlecht Languages: English and Dutch and/or French Employment Type: Freelance Start Date: ASAP End Date: 31/12/2025 Context of the mission/Objective(s) of the job: As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities. As a...

  • Project Manager

    il y a 4 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/Objective(s) of the job As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities As a Project Manager you will have a strong focus on the BUILD activities, which means that you willAct as the primary contact point towards the Business Product...

  • Atcon Global

    il y a 2 semaines

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job As a Program Manager you are part of the delivery unit Operational Planning & Competencies. You are responsible for one or several projects from a to z, meaning that you manage the delivery of the projects assigned to you in terms of scope, time, budget and quality. And this in the domain of Operational Planning...

  • Atcon Global

    il y a 2 semaines

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job As a Program Manager you are part of the delivery unit Operational Planning & Competencies. You are responsible for one or several projects from a to z, meaning that you manage the delivery of the projects assigned to you in terms of scope, time, budget and quality. And this in the domain of Operational...

  • Atcon Global

    il y a 2 semaines

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job As a Program Manager you are part of the delivery unit Operational Planning & Competencies. You are responsible for one or several projects from a to z, meaning that you manage the delivery of the projects assigned to you in terms of scope, time, budget and quality. And this in the domain of Operational...

  • Project Manager

    il y a 5 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Location: AnderlechtLanguages: English and Dutch and/or FrenchEmployment Type: FreelanceStart Date: ASAPEnd Date: 31/12/2025 Context of the mission/Objective(s) of the job:As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Responsibilities.As a Project Manager you will have a...

  • Atcon Global

    il y a 7 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the jobAs a Program Manager you are part of the delivery unit Operational Planning & Competencies. You are responsible for one or several projects from a to z, meaning that you manage the delivery of the projects assigned to you in terms of scope, time, budget and quality. And this in the domain of Operational Planning...

  • Atcon Global

    il y a 2 semaines

    Anderlecht, Brussels, Belgique Atcon Global Temps plein

    Context of the mission/objective(s) of the job As a Program Manager you are part of the delivery unit Operational Planning & Competencies. You are responsible for one or several projects from a to z, meaning that you manage the delivery of the projects assigned to you in terms of scope, time, budget and quality. And this in the domain of Operational Planning...

  • Senior Manager, Project Management

    il y a 5 jours

    Anderlecht, Belgique Atcon Global Temps plein

    Languages: English and Dutch and/or French Employment Type: Freelance Start Date: ASAP As Project Manager you will work in the Real time operations team and you will be in charge of an Incident management related project Steer the projects in your portfolio, manage/structure the project backlog, coordinate delivery and sprints scope, review and...