Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSenior
Schaftenau
from 65,605.54 / year
New Job?Nejo!
Your personal AI career agent
NONovartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 78,383.9 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Authoring high-quality regulatory documentation for global pharmaceutical submissions. Minimum 8 years regulatory or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Minimum 8 years regulatory or pharmaceutical experience
- Knowledge of regulatory submission and approval
- Ability to handle complex CMC issues
- Ability to critically evaluate scientific data
Tasks
- Formulate and drive global CMC regulatory strategies
- Lead all global CMC submission activities
- Identify documentation requirements and quality issues
- Negotiate delivery of technical source documents
- Author high-quality CMC documentation for submissions
- Review documentation for technical congruency and compliance
- Represent Global Regulatory CMC on cross-functional teams
- Maintain collaborative partnerships with project stakeholders
- Lead Health Authority interactions and negotiations
- Prepare briefing books and risk mitigation plans
- Act as the primary contact for the FDA
- Provide strategic direction through specialized assignments
Work Experience
- 8 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
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeExperiencedSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
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
Associate Director, Regulatory Affairs CMC(m/w/x)
Schaftenau
from 78,383.9 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Authoring high-quality regulatory documentation for global pharmaceutical submissions. Minimum 8 years regulatory or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Minimum 8 years regulatory or pharmaceutical experience
- Knowledge of regulatory submission and approval
- Ability to handle complex CMC issues
- Ability to critically evaluate scientific data
Tasks
- Formulate and drive global CMC regulatory strategies
- Lead all global CMC submission activities
- Identify documentation requirements and quality issues
- Negotiate delivery of technical source documents
- Author high-quality CMC documentation for submissions
- Review documentation for technical congruency and compliance
- Represent Global Regulatory CMC on cross-functional teams
- Maintain collaborative partnerships with project stakeholders
- Lead Health Authority interactions and negotiations
- Prepare briefing books and risk mitigation plans
- Act as the primary contact for the FDA
- Provide strategic direction through specialized assignments
Work Experience
- 8 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)
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 CMC(m/w/x)
Full-timeWith HomeofficeExperiencedSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year - Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / year