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Manager, Regulatory Affairs CMC(m/w/x)
Managing global regulatory submissions for pharmaceutical product chemistry, manufacturing, and controls. Science degree and two years' regulatory or pharmaceutical experience essential. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Two years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, analytics, or pharmaceutical technology
- Knowledge of regulations and product life cycle
- 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
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Chemistry
- Pharmacy
- Biochemistry
- Molecular Biology
- Biotechnology
- Biology
- Regulatory CMC
- Pharmaceutical technology
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
Not a perfect match?
- NovartisFull-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year
- Novartis
Senior Manager, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 65,605.54 / year - 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 - Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 78,383.9 / year
Manager, Regulatory Affairs CMC(m/w/x)
Managing global regulatory submissions for pharmaceutical product chemistry, manufacturing, and controls. Science degree and two years' regulatory or pharmaceutical experience essential. On-site childcare facilities.
Requirements
- Science degree or equivalent qualification
- Two years' regulatory CMC or pharmaceutical experience
- Knowledge of chemistry, analytics, or pharmaceutical technology
- Knowledge of regulations and product life cycle
- 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
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Chemistry
- Pharmacy
- Biochemistry
- Molecular Biology
- Biotechnology
- Biology
- Regulatory CMC
- Pharmaceutical technology
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
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 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 - Novartis
Associate Director, Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSeniorSchaftenaufrom 78,383.9 / year