BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Full-timeOn-siteExperienced
Basel
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Managing EU and US product labels for healthcare products, leading Health Authority responses. Three years of experience with CDS, EU, and US regulatory documents and PD Regulatory Program Management expected. Standard business hours.
Requirements
- Bachelor’s degree
- Three years of proven labeling experience
- Experience with CDS, EU, and US labels
- Experience in PD Regulatory Program Management
- Deep insight into strategic labeling
- Additional experience in market access (advantageous)
- Technical expertise in regulatory environment
- Strong project management skills
- Creative thinking for strategic proposals
- Knowledge sharing and team elevation
- Stakeholder relationship management and collaboration
- Ability to lead cross-functional matrix teams
- Strong influencing skills
- Adaptability and proactive learning mindset
- Understanding of GVP and GCP principles
Tasks
- Craft and maintain core labeling documents
- Manage EU and US local product labels
- Apply critical thinking to data messaging
- Ensure clarity in regulatory labeling documents
- Lead responses to Health Authority requests
- Guide affiliates on global label updates
- Partner with stakeholders on molecule portfolios
- Contribute to technical and healthcare initiatives
- Ensure compliance with corporate labeling policies
- Monitor industry trends and competitive landscapes
- Develop and update departmental operating procedures
- Optimize systems for content tracking and compliance
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CDS labels
- EU labels
- US labels
- Good Pharmacovigilance Practice (GVP)
- Good Clinical Practice (GCP)
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Managing EU and US product labels for healthcare products, leading Health Authority responses. Three years of experience with CDS, EU, and US regulatory documents and PD Regulatory Program Management expected. Standard business hours.
Requirements
- Bachelor’s degree
- Three years of proven labeling experience
- Experience with CDS, EU, and US labels
- Experience in PD Regulatory Program Management
- Deep insight into strategic labeling
- Additional experience in market access (advantageous)
- Technical expertise in regulatory environment
- Strong project management skills
- Creative thinking for strategic proposals
- Knowledge sharing and team elevation
- Stakeholder relationship management and collaboration
- Ability to lead cross-functional matrix teams
- Strong influencing skills
- Adaptability and proactive learning mindset
- Understanding of GVP and GCP principles
Tasks
- Craft and maintain core labeling documents
- Manage EU and US local product labels
- Apply critical thinking to data messaging
- Ensure clarity in regulatory labeling documents
- Lead responses to Health Authority requests
- Guide affiliates on global label updates
- Partner with stakeholders on molecule portfolios
- Contribute to technical and healthcare initiatives
- Ensure compliance with corporate labeling policies
- Monitor industry trends and competitive landscapes
- Develop and update departmental operating procedures
- Optimize systems for content tracking and compliance
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CDS labels
- EU labels
- US labels
- Good Pharmacovigilance Practice (GVP)
- Good Clinical Practice (GCP)
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Full-timeOn-siteExperiencedBasel - Roche
Global Head of Product Development Regulatory(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel - 1201 F. Hoffmann-La Roche AG
Data Integrity Lead(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines I GmbH
Manager, Global Pricing Data and Analytics(m/w/x)
Full-timeOn-siteSeniorBasel