Regulatory Affairs Country Head

vor 3 Monaten

Bulle, Schweiz UCB Vollzeit

**Make your mark for patients**

We are looking for a Regulatory Affairs (RA) Country Head, Switzerland who is motivated, ambitious and resilient to join us in our Intercontinental Regulatory Affairs (IC RA) team, based in our **Bulle, Switzerland** office.

**About the role**:
The RA Country Head, Switzerland is a highly driven and seasoned proactive leader with matrix management experience. The RA Country Head, Switzerland is accountable for all regulatory strategic activities related to product registration and marketing authorizations for UCB products with Swissmedic and provides operational oversight for related product registration and marketing authorization activities. Additionally, the RA Country Head, Switzerland is the primary contact point within UCB for any regulatory issues for Switzerland and is a liaison with Swissmedic.

**Who you’ll work with**:
The RA Country Head, Switzerland reports into the Regulatory Science Lead Intercontinental (IC) and UK/CH Lead. You’ll oversee the development and implementation of the local regulatory strategy for all therapeutic assets in Switzerland, consistent with the business objectives, inputting local expertise into the global regulatory strategy and global planning, in collaboration with IC Regulatory Scientists/Leads, GRLs for therapeutic assets, and Regulatory Strategy Teams. Additionally, you’ll oversee a team of external partner local regulatory colleagues for the operational implementation of product registration and marketing authorization activities for UCB products in Switzerland.

**What you’ll do**:

- Serve as the primary local point of contact for the IC Regulatory Scientists/Leads, GRLs for therapeutic assets, and Regulatory Strategy Teams, and also for the local Swiss affiliate commercial, medical and market access teams.
- Act as a working member of the Swiss affiliate extended leadership team and provide strategic input and direction with regard to both regulatory and organizational risks, opportunities and initiatives.
- Accountable that the local Swiss regulatory strategy for the products in all therapeutic areas have been negotiated (if appropriate) with the local health authority (Swissmedic) and that the regulatory risks have been identified, mitigated, and appropriately communicated.
- Responsible for ensuring that the local regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the IC Regulatory Scientists/Leads, GRLs, Regulatory Strategy Teams, Regulatory Science Lead IC and UK/CH Lead, GRA LT, and other functions as needed.
- Oversee external partner local regulatory colleagues for the operational implementation of product registration and marketing authorization activities for UCB products with Swissmedic.
- Works with Regulatory Science Lead IC and UK/CH Lead; Head of IC RA and IC RA leadership team (and globally) to drive development of regulatory standards, consistent and efficient processes, and SOPs.

**Interested? For this role we’re looking for the following education, experience, and skills**:

- Bachelor’s Degree
- Several years of pharmaceutical experience in Regulatory Affairs working with cross-functional and international teams and with knowledge and experience of Swiss regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension or license maintenance.
- Demonstrated experience facilitating and coordinating teams and processes with appropriate use of interpersonal skills.
- Experience building effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas.
- Well versed with influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions.

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 with 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.

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/color/r

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