Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSenior
Schaftenau
from 78,383.9 / year
New Job?Nejo!
Your personal AI career agent
NONovartis Pharmaceutical Manufacturing GmbH
Regulatory Affairs Associate Director, CMC(m/w/x)
Schaftenau
from 78,383.9 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global CMC regulatory strategy development and submission coordination. Strong CMC regulatory understanding and scientific data evaluation required. Modern pension scheme, childcare facilities.
Requirements
- English fluency (written and spoken)
- Scientific degree or equivalent experience
- CMC Regulatory Affairs capability
- Strong CMC regulatory understanding
- Scientific data evaluation and translation
- Pharmaceutical development/manufacturing knowledge
- Effective cross-functional collaboration and priority management
- Strong planning, organisational, and interpersonal skills
Tasks
- Develop and implement global CMC regulatory strategies
- Support regulatory activities across development and lifecycle stages
- Plan and coordinate CMC submission activities
- Author and review CMC regulatory documentation
- Identify documentation requirements and manage content alignment
- Ensure high-quality submission content and compliance
- Communicate regulatory risks and updates to project teams
- Prepare and support Health Authority interactions
- Collaborate across functions for consistent delivery
- Contribute to continuous improvement initiatives
- Support knowledge sharing within the regulatory community
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development options
Career Advancement
- Worldwide career opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
Not a perfect match?
- Novartis
Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeExperiencedSchaftenaufrom 65,605.54 / year - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year
NONovartis Pharmaceutical Manufacturing GmbH
Regulatory Affairs Associate Director, CMC(m/w/x)
Schaftenau
from 78,383.9 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global CMC regulatory strategy development and submission coordination. Strong CMC regulatory understanding and scientific data evaluation required. Modern pension scheme, childcare facilities.
Requirements
- English fluency (written and spoken)
- Scientific degree or equivalent experience
- CMC Regulatory Affairs capability
- Strong CMC regulatory understanding
- Scientific data evaluation and translation
- Pharmaceutical development/manufacturing knowledge
- Effective cross-functional collaboration and priority management
- Strong planning, organisational, and interpersonal skills
Tasks
- Develop and implement global CMC regulatory strategies
- Support regulatory activities across development and lifecycle stages
- Plan and coordinate CMC submission activities
- Author and review CMC regulatory documentation
- Identify documentation requirements and manage content alignment
- Ensure high-quality submission content and compliance
- Communicate regulatory risks and updates to project teams
- Prepare and support Health Authority interactions
- Collaborate across functions for consistent delivery
- Contribute to continuous improvement initiatives
- Support knowledge sharing within the regulatory community
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development options
Career Advancement
- Worldwide career opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis Pharmaceutical Manufacturing GmbH
Industry
Pharmaceuticals
Description
The company aims to reimagine medicine to improve and extend people's lives.
Not a perfect match?
- Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 78,383.9 / year - Novartis
Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeExperiencedSchaftenaufrom 65,605.54 / year - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year