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Senior Director, International Regulatory Affairs(m/w/x)
Description
You will develop and implement regulatory strategies for international products, ensuring compliance and quality in submissions while collaborating with various teams and mentoring regulatory staff.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Bachelor’s degree required
- •Advanced degree in life sciences preferred
- •12+ years of regulatory affairs experience
- •At least 8+ years in international regulatory affairs
- •Direct experience with major international regulatory agencies
- •Success in leading global submissions
- •Developing international regulatory strategies
- •Thorough knowledge of international regulatory frameworks
- •Strong leadership and decision-making skills
- •Project management skills with strategic outcomes
- •Excellent written and verbal communication skills
- •Experience interacting with senior leadership
- •Experience managing and mentoring regulatory professionals
- •Ability to navigate complex regulatory environments
- •High level of professionalism and accountability
Education
Work Experience
12 years
Tasks
- •Develop international regulatory strategies for products.
- •Lead planning and submission of regulatory applications.
- •Serve as liaison with global Health Authorities.
- •Collaborate with teams for clinical trials and registrations.
- •Monitor regulatory developments and assess impacts.
- •Ensure quality and compliance of regulatory submissions.
- •Develop and maintain processes for regulatory activities.
- •Partner with affiliates and consultants for submissions.
- •Support global labeling strategies and alignment.
- •Mentor and manage international regulatory team members.
- •Guide direct reports in goal setting and development.
Languages
English – Business Fluent
Benefits
Retirement Plans
- •Pension
Additional Allowances
- •Medical stipend
Competitive Pay
- •Equity
Other Benefits
- •Broad range of benefits
- CSL Behring L.L.C.Full-timeOn-siteSeniorGlattbrugg
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Senior Director, International Regulatory Affairs(m/w/x)
The AI Job Search Engine
Description
You will develop and implement regulatory strategies for international products, ensuring compliance and quality in submissions while collaborating with various teams and mentoring regulatory staff.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Bachelor’s degree required
- •Advanced degree in life sciences preferred
- •12+ years of regulatory affairs experience
- •At least 8+ years in international regulatory affairs
- •Direct experience with major international regulatory agencies
- •Success in leading global submissions
- •Developing international regulatory strategies
- •Thorough knowledge of international regulatory frameworks
- •Strong leadership and decision-making skills
- •Project management skills with strategic outcomes
- •Excellent written and verbal communication skills
- •Experience interacting with senior leadership
- •Experience managing and mentoring regulatory professionals
- •Ability to navigate complex regulatory environments
- •High level of professionalism and accountability
Education
Work Experience
12 years
Tasks
- •Develop international regulatory strategies for products.
- •Lead planning and submission of regulatory applications.
- •Serve as liaison with global Health Authorities.
- •Collaborate with teams for clinical trials and registrations.
- •Monitor regulatory developments and assess impacts.
- •Ensure quality and compliance of regulatory submissions.
- •Develop and maintain processes for regulatory activities.
- •Partner with affiliates and consultants for submissions.
- •Support global labeling strategies and alignment.
- •Mentor and manage international regulatory team members.
- •Guide direct reports in goal setting and development.
Languages
English – Business Fluent
Benefits
Retirement Plans
- •Pension
Additional Allowances
- •Medical stipend
Competitive Pay
- •Equity
Other Benefits
- •Broad range of benefits
About the Company
Denali Therapeutics Inc
Industry
Other
Description
Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The company collaborates with leading scientists and industry experts to advance effective treatments for patients.
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