Roche
Global Head of Product Development Regulatory(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Basel
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Building and leading regulatory groups for cancer drug development at a biotech firm focused on oncology. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs required. Leadership team representation, extensive international collaboration.
Requirements
- Thorough understanding of drug development process and pharmaceutical industry
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
- Strong business acumen
- Very strong strategic skills
- Proven ability to deliver on goals in a cross-functional team
- Willingness to explore new technologies and processes
- Strong leadership of people
- Excellent verbal and written skills
- Skilled in conflict resolution and negotiation
- Strong negotiating skills and creativity
- Proven ability to build trust and respect
- Proficiency in Microsoft Office applications and Veeva Vault
- Flexibility to work when needed
Tasks
- Build and lead regulatory groups
- Develop and implement regulatory strategies
- Ensure compliance with regulatory requirements and standards
- Provide strategic regulatory oversight for projects
- Represent regulatory affairs on leadership teams
- Interface with EMA and national regulators
- Provide insights on evolving regulatory policies
- Manage line management and performance development
- Establish and manage high-performance regulatory teams
- Build partnerships with key stakeholders
- Maintain trusting relationships with regulators
- Create a supportive environment for the regulatory team
- Provide strategic direction and mentorship on projects
- Apply knowledge of drug development and regulatory requirements
- Maintain up-to-date regulatory knowledge and understanding
- Ensure high quality of CTAs and MAAs
- Support establishment of new affiliates
- Develop and execute local regulatory strategies
- Leverage new technologies for efficient submissions
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office applications
- Veeva Vault
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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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BEBeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Basel
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Building and leading regulatory groups for cancer drug development at a biotech firm focused on oncology. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs required. Leadership team representation, extensive international collaboration.
Requirements
- Thorough understanding of drug development process and pharmaceutical industry
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
- Strong business acumen
- Very strong strategic skills
- Proven ability to deliver on goals in a cross-functional team
- Willingness to explore new technologies and processes
- Strong leadership of people
- Excellent verbal and written skills
- Skilled in conflict resolution and negotiation
- Strong negotiating skills and creativity
- Proven ability to build trust and respect
- Proficiency in Microsoft Office applications and Veeva Vault
- Flexibility to work when needed
Tasks
- Build and lead regulatory groups
- Develop and implement regulatory strategies
- Ensure compliance with regulatory requirements and standards
- Provide strategic regulatory oversight for projects
- Represent regulatory affairs on leadership teams
- Interface with EMA and national regulators
- Provide insights on evolving regulatory policies
- Manage line management and performance development
- Establish and manage high-performance regulatory teams
- Build partnerships with key stakeholders
- Maintain trusting relationships with regulators
- Create a supportive environment for the regulatory team
- Provide strategic direction and mentorship on projects
- Apply knowledge of drug development and regulatory requirements
- Maintain up-to-date regulatory knowledge and understanding
- Ensure high quality of CTAs and MAAs
- Support establishment of new affiliates
- Develop and execute local regulatory strategies
- Leverage new technologies for efficient submissions
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office applications
- Veeva Vault
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
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