Novartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagement
Schaftenau
from 65,605.54 / year
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NONovartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeManagement
Nejo AI Summary
Leading global CMC regulatory strategies and submission activities for advanced therapeutic medicinal products at a global pharma firm. Minimum 2 years' regulatory CMC or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent
- At least 2 years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, biotechnology, or analytics
- Knowledge of regulations and product life cycle
- Ability to evaluate scientific data
- Experience with Change Control and Cross-Functional Teams
- Documentation Management and Negotiation Skills
- Regulatory Compliance and Risk Management
- Experience with Waterfall Model
Tasks
- Lead global CMC regulatory strategies for cell and gene therapy projects
- Balance business benefits with regulatory compliance through innovative approaches
- Coordinate and implement global CMC submission activities
- Plan and author high-quality regulatory documentation for health authorities
- Identify and resolve issues regarding submission content, quality, or timelines
- Negotiate the delivery of technical source documents
- Ensure technical congruency and compliance with e-publishing requirements
- Communicate regulatory risks and strategies to cross-functional project teams
- Perform risk management assessments and share lessons learned from major submissions
- Lead interactions and negotiations with Health Authorities
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Waterfall Model
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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NONovartis
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Schaftenau
from 65,605.54 / year
Full-timeWith Home OfficeManagement
Nejo AI Summary
Leading global CMC regulatory strategies and submission activities for advanced therapeutic medicinal products at a global pharma firm. Minimum 2 years' regulatory CMC or pharmaceutical experience required. On-site childcare facilities.
Requirements
- Science degree or equivalent
- At least 2 years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, biotechnology, or analytics
- Knowledge of regulations and product life cycle
- Ability to evaluate scientific data
- Experience with Change Control and Cross-Functional Teams
- Documentation Management and Negotiation Skills
- Regulatory Compliance and Risk Management
- Experience with Waterfall Model
Tasks
- Lead global CMC regulatory strategies for cell and gene therapy projects
- Balance business benefits with regulatory compliance through innovative approaches
- Coordinate and implement global CMC submission activities
- Plan and author high-quality regulatory documentation for health authorities
- Identify and resolve issues regarding submission content, quality, or timelines
- Negotiate the delivery of technical source documents
- Ensure technical congruency and compliance with e-publishing requirements
- Communicate regulatory risks and strategies to cross-functional project teams
- Perform risk management assessments and share lessons learned from major submissions
- Lead interactions and negotiations with Health Authorities
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Waterfall Model
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
Manager, Regulatory Affairs Cell & Gene Therapies(m/w/x)
Full-timeWith HomeofficeManagementSchaftenaufrom 65,605.54 / 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
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 78,383.9 / year