Sobi
Global Publication Manager(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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Developing global CMC strategies for rare disease therapies, leading SME teams on eCTD Quality modules. 7-10 years in CMC Regulatory Affairs, expertise in global regulatory requirements required. Focus on innovative therapies for rare diseases.
Requirements
- BSc in Life Science or Advanced Degree
- 7-10 years experience in CMC Regulatory Affairs
- Expertise in global regulatory CMC requirements
- Experience in product registrations and lifecycle management
- Beneficial experience in clinical phase CMC development
- Ability to manage Health Authority interactions
- Knowledge of global regulatory guidelines
- Fluency in English
- Effective verbal and written communication skills
- High computer literacy in Office software
- Preferred experience with Veeva
- Adherence to Sobi core values
- Attention to detail and problem-solving abilities
- Good judgement in communicating risks
- Ability to represent Regulatory CMC in teams
- Ability to develop solutions for complex issues
- Independent motivation and detail-orientation
Tasks
- Develop global regulatory CMC strategies
- Ensure rapid approval of marketing applications
- Write and compile CMC submission sections
- Lead SME teams on eCTD Quality modules
- Review dossier data to identify risks
- Collaborate with stakeholders on risk mitigation
- Manage Health Authority inquiries effectively
- Negotiate with Health Authorities on CMC issues
- Maintain project plans for CMC submissions
- Evaluate manufacturing changes for global impact
- Provide guidance on ICH and FDA guidelines
- Align strategies with contract manufacturing partners
- Represent CMC on cross-functional project teams
- Store regulatory information in Veeva systems
Work Experience
- 7 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Word
- Excel
- PowerPoint
- Veeva
Benefits
Competitive Pay
- Competitive compensation
Family Support
- Emphasis on work/life balance
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
Purpose-Driven Work
- Meaningful work
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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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Developing global CMC strategies for rare disease therapies, leading SME teams on eCTD Quality modules. 7-10 years in CMC Regulatory Affairs, expertise in global regulatory requirements required. Focus on innovative therapies for rare diseases.
Requirements
- BSc in Life Science or Advanced Degree
- 7-10 years experience in CMC Regulatory Affairs
- Expertise in global regulatory CMC requirements
- Experience in product registrations and lifecycle management
- Beneficial experience in clinical phase CMC development
- Ability to manage Health Authority interactions
- Knowledge of global regulatory guidelines
- Fluency in English
- Effective verbal and written communication skills
- High computer literacy in Office software
- Preferred experience with Veeva
- Adherence to Sobi core values
- Attention to detail and problem-solving abilities
- Good judgement in communicating risks
- Ability to represent Regulatory CMC in teams
- Ability to develop solutions for complex issues
- Independent motivation and detail-orientation
Tasks
- Develop global regulatory CMC strategies
- Ensure rapid approval of marketing applications
- Write and compile CMC submission sections
- Lead SME teams on eCTD Quality modules
- Review dossier data to identify risks
- Collaborate with stakeholders on risk mitigation
- Manage Health Authority inquiries effectively
- Negotiate with Health Authorities on CMC issues
- Maintain project plans for CMC submissions
- Evaluate manufacturing changes for global impact
- Provide guidance on ICH and FDA guidelines
- Align strategies with contract manufacturing partners
- Represent CMC on cross-functional project teams
- Store regulatory information in Veeva systems
Work Experience
- 7 - 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Word
- Excel
- PowerPoint
- Veeva
Benefits
Competitive Pay
- Competitive compensation
Family Support
- Emphasis on work/life balance
Career Advancement
- Professional growth opportunities
Other Benefits
- Diversity and Inclusion
Purpose-Driven Work
- Meaningful work
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Not a perfect match?
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