Vaxcyte
Executive Director, Regulatory Affairs(m/w/x)
VollzeitFreelancenur vor OrtSenior
Zug, Visp
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
CYCytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Zug
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing global regulatory strategies for first-in-class muscle activators and inhibitors. 8+ years in biotech/pharma regulatory roles, with small molecule and cardiovascular experience required. Focus on late-stage drug development.
Anforderungen
- 10-12+ years of related work experience
- 8+ years in Regulatory Affairs CMC in Biotech/Pharmaceutical industry
- Experience in small molecule drug development
- Experience in cardiovascular therapeutic area
- Proven experience as primary RA-CMC contact to Health Authorities
- Bachelor’s degree in chemistry or related field
- Advanced degree preferred
- Excellent working knowledge of international regulatory requirements
- Solid working knowledge of core processes in small molecules
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions
- Ability to work effectively across teams and functions
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
Aufgaben
- Formulate CMC regulatory strategies based on current regulatory intelligence
- Collaborate with cross-functional project teams to develop CMC regulatory strategies
- Identify regulatory risks and represent the department in project teams
- Determine required documentation and manage delivery of approved technical documents
- Prepare, author, and maintain regulatory submission documents for global applications
- Evaluate manufacturing changes for potential product impact
- Review CMC documentation supporting regulatory submissions and communications
- Coordinate responses to queries from regulatory authorities focused on CMC
- Maintain knowledge of FDA/EMA regulations and ICH guidelines
- Ensure conformance to commitments made with regulatory agencies
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
- Build and maintain relationships with internal and external business partners
- Develop collaborative relationships with other departments for effective communication
- Manage relationships with external vendors and regulatory health authorities
- Coordinate meetings and conferences with FDA, EMA, and other regulatory authorities
- Collaborate with regulatory colleagues to provide CMC expertise
- Develop and implement regulatory operating guidelines and strategies within the team
Berufserfahrung
- 10 - 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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?
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorZug - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz
CYCytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Zug
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing global regulatory strategies for first-in-class muscle activators and inhibitors. 8+ years in biotech/pharma regulatory roles, with small molecule and cardiovascular experience required. Focus on late-stage drug development.
Anforderungen
- 10-12+ years of related work experience
- 8+ years in Regulatory Affairs CMC in Biotech/Pharmaceutical industry
- Experience in small molecule drug development
- Experience in cardiovascular therapeutic area
- Proven experience as primary RA-CMC contact to Health Authorities
- Bachelor’s degree in chemistry or related field
- Advanced degree preferred
- Excellent working knowledge of international regulatory requirements
- Solid working knowledge of core processes in small molecules
- Experience with eCTD requirements and electronic submissions
- Experience with international regulatory submissions
- Ability to work effectively across teams and functions
- Excellent oral and written communication skills
- Excellent organizational skills and attention to detail
Aufgaben
- Formulate CMC regulatory strategies based on current regulatory intelligence
- Collaborate with cross-functional project teams to develop CMC regulatory strategies
- Identify regulatory risks and represent the department in project teams
- Determine required documentation and manage delivery of approved technical documents
- Prepare, author, and maintain regulatory submission documents for global applications
- Evaluate manufacturing changes for potential product impact
- Review CMC documentation supporting regulatory submissions and communications
- Coordinate responses to queries from regulatory authorities focused on CMC
- Maintain knowledge of FDA/EMA regulations and ICH guidelines
- Ensure conformance to commitments made with regulatory agencies
- Provide regulatory advice to other functional areas
- Participate in regulatory due diligence activities
- Build and maintain relationships with internal and external business partners
- Develop collaborative relationships with other departments for effective communication
- Manage relationships with external vendors and regulatory health authorities
- Coordinate meetings and conferences with FDA, EMA, and other regulatory authorities
- Collaborate with regulatory colleagues to provide CMC expertise
- Develop and implement regulatory operating guidelines and strategies within the team
Berufserfahrung
- 10 - 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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?
- Vaxcyte
Executive Director, Regulatory Affairs(m/w/x)
VollzeitFreelancenur vor OrtSeniorZug, Visp - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorZug - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz