Novartis Pharma AG
Regulatory Affairs Associate Director, CMC(m/w/x)
Full-timeWith HomeofficeExperienced
Basel, Schaftenau
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NONovartis Pharma AG
Global Regulatory Affairs Director (Neuroscience)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for neuroscience development programs. Global regulatory affairs experience required. 4-day work week.
Requirements
- BSc or MSc in science-based discipline
- Global regulatory affairs experience
- Pharmaceutical development experience
- Leading complex global regulatory strategies
- Neuroscience regulatory experience (ideal)
- Innovative disease regulatory experience (ideal)
- Rare disease regulatory experience (ideal)
- Major global submissions experience
- Registration submissions experience
- Accelerated pathways submissions experience
- Lifecycle variations submissions experience
- Health Authority engagement understanding
- Regulatory guidance interpretation understanding
- Strategic negotiations understanding
- Core member of Global Program Teams
- Influencing development strategy
- Influencing approval strategy
- Influencing lifecycle strategy
- Excellent communication skills
- Excellent influencing skills
- Excellent problem-solving skills
Tasks
- Lead regulatory strategy for Neuroscience development programmes
- Define and drive regulatory strategy aligned with product profile
- Integrate Health Authority and regional team inputs
- Identify and mitigate regulatory risks and opportunities
- Develop and communicate global regulatory strategies
- Manage Health Authority interactions and negotiations
- Provide strategic input to development plans and labelling
- Lead global regulatory submission planning and oversight
- Review and ensure quality of regulatory submissions
- Ensure compliance with global regulatory requirements
- Support accelerated and complex regulatory submissions
- Lead and align global regulatory sub-teams
- Coach and mentor regulatory colleagues
- Represent Regulatory Affairs on program teams and task forces
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG 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 Pharma AG
Global Regulatory Affairs Director (Neuroscience)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for neuroscience development programs. Global regulatory affairs experience required. 4-day work week.
Requirements
- BSc or MSc in science-based discipline
- Global regulatory affairs experience
- Pharmaceutical development experience
- Leading complex global regulatory strategies
- Neuroscience regulatory experience (ideal)
- Innovative disease regulatory experience (ideal)
- Rare disease regulatory experience (ideal)
- Major global submissions experience
- Registration submissions experience
- Accelerated pathways submissions experience
- Lifecycle variations submissions experience
- Health Authority engagement understanding
- Regulatory guidance interpretation understanding
- Strategic negotiations understanding
- Core member of Global Program Teams
- Influencing development strategy
- Influencing approval strategy
- Influencing lifecycle strategy
- Excellent communication skills
- Excellent influencing skills
- Excellent problem-solving skills
Tasks
- Lead regulatory strategy for Neuroscience development programmes
- Define and drive regulatory strategy aligned with product profile
- Integrate Health Authority and regional team inputs
- Identify and mitigate regulatory risks and opportunities
- Develop and communicate global regulatory strategies
- Manage Health Authority interactions and negotiations
- Provide strategic input to development plans and labelling
- Lead global regulatory submission planning and oversight
- Review and ensure quality of regulatory submissions
- Ensure compliance with global regulatory requirements
- Support accelerated and complex regulatory submissions
- Lead and align global regulatory sub-teams
- Coach and mentor regulatory colleagues
- Represent Regulatory Affairs on program teams and task forces
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharma AG 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 Pharma AG
Industry
Pharmaceuticals
Description
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Not a perfect match?
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