Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSenior
Schaftenau
from 65,605.54 / year
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NONovartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Planning and authoring global regulatory documentation for pharmaceutical CMC submissions. Minimum 5 years of regulatory CMC or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Minimum 5 years of regulatory CMC or pharmaceutical experience
- Knowledge of regulatory submission and approval processes
- Ability to critically evaluate scientific data
Tasks
- Drive global CMC regulatory strategy
- Balance business benefits with regulatory compliance
- Lead global CMC submission activities
- Plan and author regulatory documentation
- Coordinate and review submission packages
- Identify content and quality issues
- Negotiate delivery of technical source documents
- Ensure technical congruency and e-publishing compliance
- Communicate regulatory risks to project teams
- Represent the department in cross-functional teams
- Lead CMC risk management assessments
- Conduct lessons learned on major submissions
- Initiate and lead Health Authority negotiations
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development options
Career Advancement
- Worldwide career opportunities
Other Benefits
- Recruitment process adjustments
- Disability representative involvement
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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- Novartis
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Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year
NONovartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Planning and authoring global regulatory documentation for pharmaceutical CMC submissions. Minimum 5 years of regulatory CMC or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Minimum 5 years of regulatory CMC or pharmaceutical experience
- Knowledge of regulatory submission and approval processes
- Ability to critically evaluate scientific data
Tasks
- Drive global CMC regulatory strategy
- Balance business benefits with regulatory compliance
- Lead global CMC submission activities
- Plan and author regulatory documentation
- Coordinate and review submission packages
- Identify content and quality issues
- Negotiate delivery of technical source documents
- Ensure technical congruency and e-publishing compliance
- Communicate regulatory risks to project teams
- Represent the department in cross-functional teams
- Lead CMC risk management assessments
- Conduct lessons learned on major submissions
- Initiate and lead Health Authority negotiations
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development options
Career Advancement
- Worldwide career opportunities
Other Benefits
- Recruitment process adjustments
- Disability representative involvement
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Not a perfect match?
- Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
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Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year - Novartis
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Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year