Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSenior
Schaftenau
from 78,383.9 / year
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NONovartis
Manager, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeOn-siteManagement
Nejo AI Summary
Leading global CMC submission activities, authoring high-quality documentation for a global pharmaceutical company. Regulatory CMC or pharmaceutical industry experience expected. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Regulatory CMC or pharmaceutical industry experience
- Knowledge of chemistry, analytics, or regulations
- Ability to critically evaluate scientific data
Tasks
- Lead global CMC regulatory strategies
- Balance business benefits with compliance
- Manage global CMC submission activities
- Coordinate technical source document delivery
- Author high-quality CMC submission documentation
- Ensure technical congruency and compliance
- Meet e-publishing and timeline requirements
- Communicate regulatory risks to stakeholders
- Represent the department in cross-functional teams
- Prepare CMC risk management assessments
- Lead Health Authority interactions and negotiations
Work Experience
- approx. 1 - 4 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.
Not a perfect match?
- Novartis Pharmaceutical Manufacturing GmbH
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NONovartis
Manager, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeOn-siteManagement
Nejo AI Summary
Leading global CMC submission activities, authoring high-quality documentation for a global pharmaceutical company. Regulatory CMC or pharmaceutical industry experience expected. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Regulatory CMC or pharmaceutical industry experience
- Knowledge of chemistry, analytics, or regulations
- Ability to critically evaluate scientific data
Tasks
- Lead global CMC regulatory strategies
- Balance business benefits with compliance
- Manage global CMC submission activities
- Coordinate technical source document delivery
- Author high-quality CMC submission documentation
- Ensure technical congruency and compliance
- Meet e-publishing and timeline requirements
- Communicate regulatory risks to stakeholders
- Represent the department in cross-functional teams
- Prepare CMC risk management assessments
- Lead Health Authority interactions and negotiations
Work Experience
- approx. 1 - 4 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
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorSchaftenaufrom 78,383.9 / year - Novartis Pharmaceutical Manufacturing GmbH
Drug Product Project Leader – Associate Director Science & Technology(m/w/x)
Full-time/Part-timeOn-siteSeniorSchaftenaufrom 78,383.9 / year - Novartis Pharmaceutical Manufacturing GmbH
QA Compliance Expert – Sampling and Manufacturing(m/w/x)
Full-timeOn-siteExperiencedKundlfrom 64,023.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Technical Transfer Lead, Medical Device(m/w/x)
Full-timeOn-siteExperiencedSchaftenaufrom 65,605.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Full-timeOn-siteSeniorSchaftenaufrom 78,383.9 / year