Grünenthal GmbH
Head Global Quality Excellence(m/w/x)
Full-time/Part-timeWith HomeofficeManagement
Aachen
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PAPAION Pharma GmbH
Associate Director Regulatory Affairs(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
Nejo AI Summary
Managing marketing authorizations and CTD submissions for anesthesia and intensive care active ingredients across EU, UK, US, JP at specialized pharma company. Seven years pharma industry experience and profound EU CTR 536/2014 knowledge required. 30 days vacation, flexible working hours, partial remote work.
Requirements
- Seven years pharmaceutical industry experience
- Five years Regulatory Affairs experience
- Knowledge of EU regulatory framework
- Regulatory Life Cycle Management expertise
- Profound knowledge of EU CTR 536/2014
- Profound experience with CTIS
- Good self-management
- Strong sense of responsibility
- Attention to details
- Ability to connect with partners
- University degree on Science
- Business fluent English
- Fluent German or EU language beneficial
Tasks
- Manage marketing authorizations across EU, UK, US, and JP markets
- Oversee regulatory affairs management for license partners
- Manage CTD submissions including variations, extensions, and renewals
- Provide strong support for clinical development initiatives
- Lead regulatory interactions and documentation for health authorities
- Establish and implement regulatory strategies aligned with company goals
- Maintain IB, PBRER, DSUR, CCDS, and related documents
- Manage and update standard operating procedures
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CTIS
- CP
- DCP
- MRP
- NP
Benefits
Flexible Working
- Flexible working hours
- Partial remote work
More Vacation Days
- 30 days of vacation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PAION Pharma GmbH 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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PAPAION Pharma GmbH
Associate Director Regulatory Affairs(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
Nejo AI Summary
Managing marketing authorizations and CTD submissions for anesthesia and intensive care active ingredients across EU, UK, US, JP at specialized pharma company. Seven years pharma industry experience and profound EU CTR 536/2014 knowledge required. 30 days vacation, flexible working hours, partial remote work.
Requirements
- Seven years pharmaceutical industry experience
- Five years Regulatory Affairs experience
- Knowledge of EU regulatory framework
- Regulatory Life Cycle Management expertise
- Profound knowledge of EU CTR 536/2014
- Profound experience with CTIS
- Good self-management
- Strong sense of responsibility
- Attention to details
- Ability to connect with partners
- University degree on Science
- Business fluent English
- Fluent German or EU language beneficial
Tasks
- Manage marketing authorizations across EU, UK, US, and JP markets
- Oversee regulatory affairs management for license partners
- Manage CTD submissions including variations, extensions, and renewals
- Provide strong support for clinical development initiatives
- Lead regulatory interactions and documentation for health authorities
- Establish and implement regulatory strategies aligned with company goals
- Maintain IB, PBRER, DSUR, CCDS, and related documents
- Manage and update standard operating procedures
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- CTIS
- CP
- DCP
- MRP
- NP
Benefits
Flexible Working
- Flexible working hours
- Partial remote work
More Vacation Days
- 30 days of vacation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PAION Pharma GmbH 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
PAION Pharma GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein spezialisiertes Pharmaunternehmen im Bereich Anästhesie und Intensivpflege, das innovative Wirkstoffe für den Einsatz bei Patienten in Kliniken und ambulant entwickelt.
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