Idorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Full-timeOn-siteSenior
Basel
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IDIdorsia Pharmaceuticals Ltd
Global Regulatory Lead(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy development for small-molecule drugs, supporting lifecycle management and health authority interactions. 5+ years of global filing and submission approval experience required. International exposure, collaborative culture.
Requirements
- Master's Degree in life sciences
- At least 5 years of regulatory experience or other relevant drug development experience
- Leading global and/or regional filings
- Reviews and approvals of major submissions to Health Authorities
- Leading Health Authority interactions
- In-depth knowledge of regulatory legislation and guidelines (ICH, US and EU)
- Strong understanding of regulatory aspects across development stages
- In-depth experience working, communicating and negotiating with Health Authorities
- Strong scientific competence and familiarity with clinical trial methodology and statistics
- Proven development experience
- Proven experience as successful leader in strategic cross-functional and matrix environments
- Excellent communication, interpersonal, negotiation and problem-solving skills
- Very good understanding of interrelationships between functions, departments and business priorities
- Effective team player, able to work independently in cross-functional and global teams
- Ability to work within tight timelines with excellent project management skills
- Excellent spoken and written English
Tasks
- Support medicinal product development and lifecycle management globally
- Develop and execute regulatory strategies in Europe and other regions
- Represent Global Regulatory Affairs in cross-functional and governance forums
- Collaborate with stakeholders on labeling, safety, and commercial teams
- Ensure aligned and effective decision-making
- Define optimal global regulatory strategies for new compounds
- Manage product lifecycle activities for assigned products
- Review global promotional material before country-specific review
- Lead creation, review, and finalization of CCDS
- Communicate CCDS changes to affiliates or partners
- Provide regulatory support for other countries with affiliates or partners
- Lead global submission planning process
- Create, review, and finalize key regulatory submission documents
- Represent GRA at LCT and management committee meetings
- Collaborate with US Regulatory Lead on strategy and documents
- Interpret HA regulatory guidelines for drug development and lifecycle
- Ensure compliance with global regulatory guidelines and processes
- Represent GRA at audits and inspections
- Achieve RA project milestones
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Growth and learning opportunities
Informal Culture
- Collaborative culture
- Encourages teamwork, initiative, and new ideas
- International exposure
- Multicultural setting
Startup Environment
- Supportive environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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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IDIdorsia Pharmaceuticals Ltd
Global Regulatory Lead(m/w/x)
Allschwil
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy development for small-molecule drugs, supporting lifecycle management and health authority interactions. 5+ years of global filing and submission approval experience required. International exposure, collaborative culture.
Requirements
- Master's Degree in life sciences
- At least 5 years of regulatory experience or other relevant drug development experience
- Leading global and/or regional filings
- Reviews and approvals of major submissions to Health Authorities
- Leading Health Authority interactions
- In-depth knowledge of regulatory legislation and guidelines (ICH, US and EU)
- Strong understanding of regulatory aspects across development stages
- In-depth experience working, communicating and negotiating with Health Authorities
- Strong scientific competence and familiarity with clinical trial methodology and statistics
- Proven development experience
- Proven experience as successful leader in strategic cross-functional and matrix environments
- Excellent communication, interpersonal, negotiation and problem-solving skills
- Very good understanding of interrelationships between functions, departments and business priorities
- Effective team player, able to work independently in cross-functional and global teams
- Ability to work within tight timelines with excellent project management skills
- Excellent spoken and written English
Tasks
- Support medicinal product development and lifecycle management globally
- Develop and execute regulatory strategies in Europe and other regions
- Represent Global Regulatory Affairs in cross-functional and governance forums
- Collaborate with stakeholders on labeling, safety, and commercial teams
- Ensure aligned and effective decision-making
- Define optimal global regulatory strategies for new compounds
- Manage product lifecycle activities for assigned products
- Review global promotional material before country-specific review
- Lead creation, review, and finalization of CCDS
- Communicate CCDS changes to affiliates or partners
- Provide regulatory support for other countries with affiliates or partners
- Lead global submission planning process
- Create, review, and finalize key regulatory submission documents
- Represent GRA at LCT and management committee meetings
- Collaborate with US Regulatory Lead on strategy and documents
- Interpret HA regulatory guidelines for drug development and lifecycle
- Ensure compliance with global regulatory guidelines and processes
- Represent GRA at audits and inspections
- Achieve RA project milestones
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Growth and learning opportunities
Informal Culture
- Collaborative culture
- Encourages teamwork, initiative, and new ideas
- International exposure
- Multicultural setting
Startup Environment
- Supportive environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd 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
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Not a perfect match?
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Global Head of Product Development Regulatory(m/w/x)
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Swiss Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Regulatory Labeling Manager(m/w/x)
Full-timeOn-siteExperiencedBasel