Regulatory Cmc

2 weeks ago

Toronto, Canada UCB S.A. Full time

**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 management solutions and support the GRA-CMC & Devices projects activities. A CMC & Devices PM’s role is to initiate, plan, execute, monitor/control and report on the CMC & Devices Portfolio activities.

As a **Regulatory CMC & Devices Project Manager** you will have the following responsibilities:

- Collaborate on the development of strategic plan (charter) for the project with focus on GRA-CMC & Devices and collaboration with the technical organization (S&TS).
- Identify internal team synergies and/or conflicts early and propose solutions in agreement with stakeholders.
- Stakeholder management with relevant interfaces
- Scenario planning for the asset/project and Portfolio
- Plan, track and monitor project progress across all Submission aspects, identifying problems, forecasting risks, and proactively seeking resolutions.
- Ensure communication, alignment and integration between sub-projects, across Practices and other stakeholders incl. priority setting of different activities and deliverables
- Manage project tools and provide support to the CMC & Devices team, e.g. Integrate, SharePoint, Integrated Project Plan as required by the project.
- Create visibility and reporting on CMC & Devices portfolio.
- Create communications for internal and external stakeholders (content perspective) incl. information gathering, making sure strategic concepts are in alignment

Interested? For this position you’ll need the following **education**, **experience** and **skills**:

- Bachelor’s Degree in a science or business-related field is required
- Several years’ experience as a project manager leading complex projects in a multi-disciplinary, global environment is required
- Experience in Regulatory Affairs, CMC preferred
- Advanced expertise with project management related software and tools -Advanced expertise in Planisware would be a strong plus.

RANDATUCB

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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