Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSenior
Basel
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IDIdorsia Pharmaceuticals Ltd
Senior Technical Regulatory Affairs Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
- Veeva
- DocuBridge
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
Senior Technical Regulatory Affairs Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
- Veeva
- DocuBridge
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?
- Idorsia Pharmaceuticals Ltd
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Full-timeOn-siteExperiencedBasel - Roche
Regulatory Labeling Manager(m/w/x)
Full-timeOn-siteExperiencedBasel - Abbott
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