BridgeBio Pharma
Senior Director, Market Access, Europe Central Region(m/w/x)
Vollzeitmit HomeofficeSenior
München, Zug
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CYCytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Zug
VollzeitFreelancemit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading European regulatory strategy and MAA submissions for cardiovascular biopharmaceuticals. 10+ years of European regulatory expertise required. Collaboration with global teams and cross-functional departments.
Anforderungen
- Minimum 10 years relevant experience
- Expertise in European regulatory regulations
- Bachelor of Science in scientific discipline
- Pharm D or PhD preferred
- Fluency in English
- Other key EU market languages advantage
- Leading MAA through EMA centralized procedure
- Leading MAA through national agencies
- Experience in international markets advantageous
- Leading regulatory agency interactions
- Participating in regulatory agency interactions
- Solid foundation in science
- Strong team player
- Engaged, hands-on professional
- Collaborative and independent work
- Excellent verbal communication skills
- Excellent written communication skills
- Excellent planning skills
- Excellent organization skills
- Excellent time management skills
- Ability to support multiple projects
- Ability to prioritize multiple projects
- Strong interpersonal capabilities
- Ability to build networks
- Ability to maintain networks
- Sense of urgency
- Identifies challenges and problems
- Initiative to identify solutions
Aufgaben
- Develop and execute regulatory strategies for European programs
- Lead submission of Marketing Authorization Applications for Cytokinetics products
- Implement post-marketing requirements for European products
- Collaborate with the Global Regulatory Lead and Global Regulatory Team
- Work cross-functionally with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access, and country operations
- Maintain awareness of the European regulatory environment
- Communicate the impact of regulatory changes on business and product development
- Develop a robust European strategy for specific products
- Contribute to and execute filing plans for Europe
- Ensure high-quality regulatory submissions are timely and meet Cytokinetics requirements
- Review and provide strategic input on EU CTR submissions and queries
- Provide direction on regional and local regulatory mechanisms
- Contribute to EMA and national agencies interactions and preparations
- Stay informed about new and developing legislation and regulatory policies
- Discuss implications of regulatory changes with the business
- Provide regulatory input to market access strategy and HTA plans
- Ensure all post-marketing requirements and maintenance activities are met
- Work with the Quality department on European regulatory procedures
Berufserfahrung
- 10 Jahre
Ausbildung
- Pflichtschulabschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
- Spanisch – Grundkenntnisse
- Italienisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Cytokinetics 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?
- Alnylam Pharmaceuticals
Associate Director, Marketing - International TTR BU(m/w/x)
Vollzeitmit HomeofficeSeniorZug - Alnylam Pharmaceuticals, Inc.
Associate Director, Medical Training(m/w/x)
Vollzeitmit HomeofficeSeniorZug - AbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenCham - Apellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Vollzeitmit HomeofficeSeniorZug
CYCytokinetics
Director, Regulatory Affairs, Europe(m/w/x)
Zug
VollzeitFreelancemit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading European regulatory strategy and MAA submissions for cardiovascular biopharmaceuticals. 10+ years of European regulatory expertise required. Collaboration with global teams and cross-functional departments.
Anforderungen
- Minimum 10 years relevant experience
- Expertise in European regulatory regulations
- Bachelor of Science in scientific discipline
- Pharm D or PhD preferred
- Fluency in English
- Other key EU market languages advantage
- Leading MAA through EMA centralized procedure
- Leading MAA through national agencies
- Experience in international markets advantageous
- Leading regulatory agency interactions
- Participating in regulatory agency interactions
- Solid foundation in science
- Strong team player
- Engaged, hands-on professional
- Collaborative and independent work
- Excellent verbal communication skills
- Excellent written communication skills
- Excellent planning skills
- Excellent organization skills
- Excellent time management skills
- Ability to support multiple projects
- Ability to prioritize multiple projects
- Strong interpersonal capabilities
- Ability to build networks
- Ability to maintain networks
- Sense of urgency
- Identifies challenges and problems
- Initiative to identify solutions
Aufgaben
- Develop and execute regulatory strategies for European programs
- Lead submission of Marketing Authorization Applications for Cytokinetics products
- Implement post-marketing requirements for European products
- Collaborate with the Global Regulatory Lead and Global Regulatory Team
- Work cross-functionally with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access, and country operations
- Maintain awareness of the European regulatory environment
- Communicate the impact of regulatory changes on business and product development
- Develop a robust European strategy for specific products
- Contribute to and execute filing plans for Europe
- Ensure high-quality regulatory submissions are timely and meet Cytokinetics requirements
- Review and provide strategic input on EU CTR submissions and queries
- Provide direction on regional and local regulatory mechanisms
- Contribute to EMA and national agencies interactions and preparations
- Stay informed about new and developing legislation and regulatory policies
- Discuss implications of regulatory changes with the business
- Provide regulatory input to market access strategy and HTA plans
- Ensure all post-marketing requirements and maintenance activities are met
- Work with the Quality department on European regulatory procedures
Berufserfahrung
- 10 Jahre
Ausbildung
- Pflichtschulabschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
- Spanisch – Grundkenntnisse
- Italienisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Cytokinetics 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
Cytokinetics
Branche
Pharmaceuticals
Beschreibung
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on developing first-in-class muscle activators and inhibitors.
Noch nicht perfekt?
- BridgeBio Pharma
Senior Director, Market Access, Europe Central Region(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen, Zug - Alnylam Pharmaceuticals
Associate Director, Marketing - International TTR BU(m/w/x)
Vollzeitmit HomeofficeSeniorZug - Alnylam Pharmaceuticals, Inc.
Associate Director, Medical Training(m/w/x)
Vollzeitmit HomeofficeSeniorZug - AbbVie
Affiliate Safety Representative (ASR)(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenCham - Apellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Vollzeitmit HomeofficeSeniorZug