Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
IDIdorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing Module 2/3 CTDs and IMPD/IND for small-molecule drug applications. 5+ years in technical/CMC regulatory field or similar pharma industry positions required. Focus on small-molecule drug pipeline, global regulatory scope.
Anforderungen
- University degree (Msc, PhD) in Pharmacy (Pharm D), Chemistry, biology, or alternative technical/science university degree
- At least 5 years experience in technical/CMC regulatory field or similar pharmaceutical industry positions
- Good organizational and communication skills
- Proactive initiation and leadership in CMC documentation preparation for filing
- Ability to manage multiple tasks with competing priorities
- Ability to manage complex projects
- Clear and professional verbal and written communication skills
- Good MS Office, Veeva, DocuBridge skills
- Good spoken and excellent written English
- Knowledge of any other European language (advantageous)
- Knowledge and understanding of ICH guidelines (Quality), GMP requirements, and Regulatory procedures (US-FDA, EU-CHMP, Health Canada, Swissmedic, Japanese PMDA, Chinese FDA)
- Advanced knowledge of drug substance/product development, manufacturing, quality control, packaging, and regulatory environment
Aufgaben
- Manage Module 2 and 3 CTDs for global marketing applications
- Manage Quality sections of IMPD and IND for clinical trials
- Manage other technical regulatory documents for clinical trials
- Prepare Briefing Books for Health Authority meetings
- Prepare supportive documentation for Health Authority meetings
- Respond to Health Authority quality questions on applications and variations
- Negotiate, plan, and coordinate regulatory strategies with stakeholders
- Coordinate strategies for regulatory submissions and supplies
- Assess regulatory impact of product changes
- Communicate regulatory requirements for product changes
- Store and track regulatory document versions in management systems
- Track global submissions, approvals, and implementation dates
- Contribute to operational and strategic forms, guidelines, and procedures
- Organize reviews with CMC and management teams
- Assess comments from document reviews
- Consolidate technical documents for global submissions
- Ensure consistency of raw data and registration documents
- Prepare and track pre and post approval synopsis
- Store technical regulatory documents in management systems
- Utilize dictionaries and metadata for document storage
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Veeva
- DocuBridge
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
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Regulatory Labeling Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Abbott
Quality Assurance Manager – Third Party Manufacturing & Technical Transfer(m/w/x)
Vollzeitnur vor OrtSeniorBasel, Allschwil
IDIdorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing Module 2/3 CTDs and IMPD/IND for small-molecule drug applications. 5+ years in technical/CMC regulatory field or similar pharma industry positions required. Focus on small-molecule drug pipeline, global regulatory scope.
Anforderungen
- University degree (Msc, PhD) in Pharmacy (Pharm D), Chemistry, biology, or alternative technical/science university degree
- At least 5 years experience in technical/CMC regulatory field or similar pharmaceutical industry positions
- Good organizational and communication skills
- Proactive initiation and leadership in CMC documentation preparation for filing
- Ability to manage multiple tasks with competing priorities
- Ability to manage complex projects
- Clear and professional verbal and written communication skills
- Good MS Office, Veeva, DocuBridge skills
- Good spoken and excellent written English
- Knowledge of any other European language (advantageous)
- Knowledge and understanding of ICH guidelines (Quality), GMP requirements, and Regulatory procedures (US-FDA, EU-CHMP, Health Canada, Swissmedic, Japanese PMDA, Chinese FDA)
- Advanced knowledge of drug substance/product development, manufacturing, quality control, packaging, and regulatory environment
Aufgaben
- Manage Module 2 and 3 CTDs for global marketing applications
- Manage Quality sections of IMPD and IND for clinical trials
- Manage other technical regulatory documents for clinical trials
- Prepare Briefing Books for Health Authority meetings
- Prepare supportive documentation for Health Authority meetings
- Respond to Health Authority quality questions on applications and variations
- Negotiate, plan, and coordinate regulatory strategies with stakeholders
- Coordinate strategies for regulatory submissions and supplies
- Assess regulatory impact of product changes
- Communicate regulatory requirements for product changes
- Store and track regulatory document versions in management systems
- Track global submissions, approvals, and implementation dates
- Contribute to operational and strategic forms, guidelines, and procedures
- Organize reviews with CMC and management teams
- Assess comments from document reviews
- Consolidate technical documents for global submissions
- Ensure consistency of raw data and registration documents
- Prepare and track pre and post approval synopsis
- Store technical regulatory documents in management systems
- Utilize dictionaries and metadata for document storage
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Veeva
- DocuBridge
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?
- Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Idorsia
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Regulatory Labeling Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Abbott
Quality Assurance Manager – Third Party Manufacturing & Technical Transfer(m/w/x)
Vollzeitnur vor OrtSeniorBasel, Allschwil