BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IDIdorsia Pharmaceuticals Ltd
Global Regulatory Lead(m/w/x)
Allschwil
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Weiterbildungsangebote
- Growth and learning opportunities
Lockere Unternehmenskultur
- Collaborative culture
- Encourages teamwork, initiative, and new ideas
- International exposure
- Multicultural setting
Startup-Atmosphäre
- Supportive environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Idorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global Head of Product Development Regulatory(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Brenntag Schweizerhall AG
Swiss Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Regulatory Labeling Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel
IDIdorsia Pharmaceuticals Ltd
Global Regulatory Lead(m/w/x)
Allschwil
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Weiterbildungsangebote
- Growth and learning opportunities
Lockere Unternehmenskultur
- Collaborative culture
- Encourages teamwork, initiative, and new ideas
- International exposure
- Multicultural setting
Startup-Atmosphäre
- Supportive environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Idorsia Pharmaceuticals Ltd
Branche
Pharmaceuticals
Beschreibung
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Idorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global Head of Product Development Regulatory(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Brenntag Schweizerhall AG
Swiss Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Regulatory Labeling Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel