Global Labeling Associate/ Global Regulatory

vor 7 Monaten

Bern, Schweiz We make it Vollzeit

Beschreibung:
We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company CSL Behring in Bern, we are looking for a Global Labeling Associate (GLA) (M/F/d)

**Global Labeling Associate 80% (M/F/d)**:
**Background**

About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

**Tasks & Responsibilities**
- Lead, communicate and manage tactical activities of the E2E submission and implementation phases of all labeling changes in regional and local product information and packaging to final printed packaging materials.
- Lead, manage and support implementation of on-going global projects with labeling impact to the foundational markets and rest of world.
- Manage, track assigned global projects with labeling impacts and monitor implementation worldwide.
- Interface with impacted stakeholders for the maintenance and implementation of approved labeling variations into the electronic or printed package materials
- Support GLO in providing foundational markets (Australia, Switzerland, Germany, EU and US) labels to GRA Region and ROW for NDAs, renewals, CPPs and request of labeling verification statements.
- Collaborate and manage functional SMEs on vaccines Annual Strain Update (ASU) pre
- and postactivities: Northern-ASU and Southern-ASU hemispheres.
- Coordinate, manage and implement labeling assessment in RIMS, and Trackwise system for global labeling changes.
- Support pre
- and post-submission labeling activities for foundational markets.
- Coordinate and manage GCC-related activities; RA Assessment and LCI collaboration with Submission Coordinator and GL Compliance
- Ensure first time quality and compliance in all aspects of labeling with detailed packages delivered in a timely manner.
- Manage and distribute English manuscripts for multimarket labels based on EU CP/MRP/DCP
- Prepare and distribute EU (MRP/CP/DCP) and US Foundational labeling package to EU- and USdependent markets.
- Collaborate with EU-GRA Lead in coordination of labeling activities for EU CP/MRP/DCP submissions (i.e., linguistic review, national translations)

May support GLO strategy team with:

- Review and assess ROW labels differences (DTT) from core and Foundational dependent market
- Prepare and distribute Foundational packages to DE and CH dependent markets.
- Management and distribution of English multi-market manuscripts based on CCDS, DE and CH to dependent markets
- Prepare and distribute labeling packages to Toll markets / regions

**Must Haves**
- University Degree
- several years of professional experience in Global Regulatory Affairs
- min. 6 years of professional experience in labelling
- Effective written and oral communication skills
- Fluent in English
- Knowledge in Trackwise, Documentum, etc.

**Nice to Haves**
- German knowledge

**Work hours**
- 30 hours / Week

**Are you interested?**

We look forward to hearing from you.

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