Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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RERevolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Developing and executing European CMC regulatory strategies for novel targeted therapies. 15+ years drug development experience, with 5+ years in EU CMC regulatory affairs, required. Support for clinical trial applications and marketing authorizations.
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
- Advanced degree (PhD, PharmD, MSc) desirable
- Minimum 15 years pharmaceutical/biotech drug development experience
- At least 5 years CMC regulatory affairs experience with European focus
- Strong expertise in EU CMC regulatory requirements
- Expertise in MAAs, variations, and lifecycle management
- Direct hands-on experience preparing/submitting regulatory documentation
- Experience supporting health agency review/approval procedures
- Experience with post approval activities
- Demonstrated experience supporting EMA submissions
- Demonstrated experience supporting EMA interactions
- Deep knowledge of EU GMP regulations
- Deep knowledge of ICH guidelines
- Ability to apply GMP and ICH guidelines across product lifecycle
- Experience with small molecules (NCEs)
- Experience managing complex CMC technical documentation
- Proven ability to lead regulatory strategy for European approvals
- Experience within global development programs
- Strong leadership skills
- Strong project management skills
- Ability to manage multiple complex programs
- Excellent communication skills
- Excellent stakeholder management skills
- Experience working cross-functionally
- Experience working with external partners
- Ability to operate effectively in a fast-paced environment
- Ability to operate effectively in a matrixed environment
- Ability to operate effectively in a global environment
Tasks
- Support clinical trial applications and regulatory interactions
- Ensure alignment with EU requirements and timelines
- Develop and execute European CMC regulatory strategies
- Support initial marketing authorizations and lifecycle management
- Prepare, review, and submit high-quality CMC dossiers
- Manage interactions with EMA, NCAs, and other European regulatory bodies
- Provide strategic input into global regulatory strategies
- Address EU-specific requirements and expectations
- Assess regulatory impact of CMC changes
- Provide proactive, risk-based guidance
- Interpret and apply EU regulatory requirements
- Support efficient regulatory pathways and compliance
- Monitor and communicate evolving regulatory expectations
- Anticipate regulatory risks and develop mitigation strategies
- Partner with global Regulatory Affairs, Quality, and Technical Operations
- Ensure consistent and compliant execution of submissions
- Represent CMC regulatory on cross-functional teams
- Ensure alignment between global strategy and regional execution
- Provide leadership and mentorship to team members
- Contribute to building regional CMC regulatory expertise
- Oversee external vendors and CROs
- Ensure timely, high-quality regulatory submissions and approvals
Work Experience
- 15 years
Education
- Bachelor's degreeOR
- Master'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 Revolution Medicines 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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RERevolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Developing and executing European CMC regulatory strategies for novel targeted therapies. 15+ years drug development experience, with 5+ years in EU CMC regulatory affairs, required. Support for clinical trial applications and marketing authorizations.
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline
- Advanced degree (PhD, PharmD, MSc) desirable
- Minimum 15 years pharmaceutical/biotech drug development experience
- At least 5 years CMC regulatory affairs experience with European focus
- Strong expertise in EU CMC regulatory requirements
- Expertise in MAAs, variations, and lifecycle management
- Direct hands-on experience preparing/submitting regulatory documentation
- Experience supporting health agency review/approval procedures
- Experience with post approval activities
- Demonstrated experience supporting EMA submissions
- Demonstrated experience supporting EMA interactions
- Deep knowledge of EU GMP regulations
- Deep knowledge of ICH guidelines
- Ability to apply GMP and ICH guidelines across product lifecycle
- Experience with small molecules (NCEs)
- Experience managing complex CMC technical documentation
- Proven ability to lead regulatory strategy for European approvals
- Experience within global development programs
- Strong leadership skills
- Strong project management skills
- Ability to manage multiple complex programs
- Excellent communication skills
- Excellent stakeholder management skills
- Experience working cross-functionally
- Experience working with external partners
- Ability to operate effectively in a fast-paced environment
- Ability to operate effectively in a matrixed environment
- Ability to operate effectively in a global environment
Tasks
- Support clinical trial applications and regulatory interactions
- Ensure alignment with EU requirements and timelines
- Develop and execute European CMC regulatory strategies
- Support initial marketing authorizations and lifecycle management
- Prepare, review, and submit high-quality CMC dossiers
- Manage interactions with EMA, NCAs, and other European regulatory bodies
- Provide strategic input into global regulatory strategies
- Address EU-specific requirements and expectations
- Assess regulatory impact of CMC changes
- Provide proactive, risk-based guidance
- Interpret and apply EU regulatory requirements
- Support efficient regulatory pathways and compliance
- Monitor and communicate evolving regulatory expectations
- Anticipate regulatory risks and develop mitigation strategies
- Partner with global Regulatory Affairs, Quality, and Technical Operations
- Ensure consistent and compliant execution of submissions
- Represent CMC regulatory on cross-functional teams
- Ensure alignment between global strategy and regional execution
- Provide leadership and mentorship to team members
- Contribute to building regional CMC regulatory expertise
- Oversee external vendors and CROs
- Ensure timely, high-quality regulatory submissions and approvals
Work Experience
- 15 years
Education
- Bachelor's degreeOR
- Master'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 Revolution Medicines 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
Revolution Medicines
Industry
Pharmaceuticals
Description
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
Not a perfect match?
- Revolution Medicines
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