Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSenior
Zug
New Job?Nejo!
Your personal AI career agent
VAVaxcyte
Executive Director, Regulatory Affairs – Clinical European/Global Focus(m/w/x)
Zug, Visp
Full-timeOn-siteManagement
Nejo AI Summary
Global clinical regulatory strategy development and CMC documentation authoring for vaccine innovation. 15+ years industry experience required, graduate education a plus. Equity component, comprehensive benefits.
Requirements
- BA or BS in relevant scientific/technical discipline (clinical pharmacology, immunology, biology, medicine, bioanalytics, life sciences)
- 15+ years industry experience demonstrating technical and regulatory expertise
- Graduate education or professional certifications/training in regulatory/quality (bonus)
- Alternative combinations of education/experience considered
- 10+ years extensive regulatory experience in pharma/biotech
- Proven record developing/prosecuting regulatory submissions/approvals
- Emphasis on vaccines and clinical content
- Thorough understanding of clinical development and statistics
- Particular experience with vaccine development and commercialization
- Direct experience engaging multiple health authorities (FDA, EMA, MHRA, Health Canada)
- Preparation of regulatory applications for global health authorities
- Demonstrated ability to lead/manage cross-functional teams
- Developing/establishing regulatory strategies
- Preparing regulatory applications (clinical/pre-clinical)
- Direct experience developing clinical regulatory strategies and submissions
- Effectively manage labelling for global markets
- Manage post-approval changes/optimizations for commercial vaccines
- Demonstrated record identifying clinical/regulatory risks
- Developing strategies/contingencies for risk mitigation
- Experience translating/integrating contemporary regulatory intelligence
- Integrating intelligence into internal policies and practice
- Articulate oral and written communication skills
- Active listening skills
- Strategic and tactical critical thinking
- Constructive operational productivity
- Adaptability
- Flexible and optimistic demeanor
Tasks
- Develop and execute global clinical regulatory strategies
- Author and review regulatory CMC documentation for submissions
- Provide regulatory guidance to cross-functional development teams
- Ensure compliance with current regulatory requirements and guidance
- Serve as primary contact with regulatory authorities
- Contribute to product label claims and clinical outcome justifications
- Lead negotiations with global regulatory authorities
- Support safety and pharmacovigilance notifications
- Provide updates on regulatory intelligence and legislation changes
- Manage cross-functional teams for regulatory compliance
- Develop and manage people (optional)
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation
- Equity component
Other Benefits
- Comprehensive benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte 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.
Not a perfect match?
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Gilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Head Environmental Regulatory Affairs(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz
VAVaxcyte
Executive Director, Regulatory Affairs – Clinical European/Global Focus(m/w/x)
Zug, Visp
Full-timeOn-siteManagement
Nejo AI Summary
Global clinical regulatory strategy development and CMC documentation authoring for vaccine innovation. 15+ years industry experience required, graduate education a plus. Equity component, comprehensive benefits.
Requirements
- BA or BS in relevant scientific/technical discipline (clinical pharmacology, immunology, biology, medicine, bioanalytics, life sciences)
- 15+ years industry experience demonstrating technical and regulatory expertise
- Graduate education or professional certifications/training in regulatory/quality (bonus)
- Alternative combinations of education/experience considered
- 10+ years extensive regulatory experience in pharma/biotech
- Proven record developing/prosecuting regulatory submissions/approvals
- Emphasis on vaccines and clinical content
- Thorough understanding of clinical development and statistics
- Particular experience with vaccine development and commercialization
- Direct experience engaging multiple health authorities (FDA, EMA, MHRA, Health Canada)
- Preparation of regulatory applications for global health authorities
- Demonstrated ability to lead/manage cross-functional teams
- Developing/establishing regulatory strategies
- Preparing regulatory applications (clinical/pre-clinical)
- Direct experience developing clinical regulatory strategies and submissions
- Effectively manage labelling for global markets
- Manage post-approval changes/optimizations for commercial vaccines
- Demonstrated record identifying clinical/regulatory risks
- Developing strategies/contingencies for risk mitigation
- Experience translating/integrating contemporary regulatory intelligence
- Integrating intelligence into internal policies and practice
- Articulate oral and written communication skills
- Active listening skills
- Strategic and tactical critical thinking
- Constructive operational productivity
- Adaptability
- Flexible and optimistic demeanor
Tasks
- Develop and execute global clinical regulatory strategies
- Author and review regulatory CMC documentation for submissions
- Provide regulatory guidance to cross-functional development teams
- Ensure compliance with current regulatory requirements and guidance
- Serve as primary contact with regulatory authorities
- Contribute to product label claims and clinical outcome justifications
- Lead negotiations with global regulatory authorities
- Support safety and pharmacovigilance notifications
- Provide updates on regulatory intelligence and legislation changes
- Manage cross-functional teams for regulatory compliance
- Develop and manage people (optional)
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation
- Equity component
Other Benefits
- Comprehensive benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte 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
Vaxcyte
Industry
Pharmaceuticals
Description
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
Not a perfect match?
- Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Gilead Sciences Switzerland Sarl
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate(m/w/x)
Full-timeOn-siteSeniorZug - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Head Environmental Regulatory Affairs(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz