Grünenthal GmbH
CMC Compliance Strategy Manager - Integrations(m/w/x)
Full-timeWith HomeofficeSenior
Aachen
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PAION Pharma GmbHAssociate Director Regulatory Affairs(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
Description
You will drive commercial success by managing global marketing authorizations and regulatory strategies, ensuring products remain compliant while leading vital authority interactions.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Bachelor's degree
Work Experience
5 - 7 years
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
Tools & Technologies
CTISCPDCPMRPNP
Languages
English – Business Fluent
German – Business Fluent
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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PA
PAION Pharma GmbHAssociate Director Regulatory Affairs(m/w/x)
Aachen
Full-timeWith Home OfficeSenior
New Job?Nejo!
The AI Job Search Engine
Description
You will drive commercial success by managing global marketing authorizations and regulatory strategies, ensuring products remain compliant while leading vital authority interactions.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Bachelor's degree
Work Experience
5 - 7 years
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
Tools & Technologies
CTISCPDCPMRPNP
Languages
English – Business Fluent
German – Business Fluent
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.
Not a perfect match?
- Grünenthal GmbH
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Full-timeWith HomeofficeSeniorAachen - Grünenthal GmbH
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Full-timeWith HomeofficeSeniorAachen - Grünenthal GmbH
Head of Medical Global Established Medicines(m/w/x)
Full-timeWith HomeofficeManagementAachen - Grünenthal GmbH
Biostatistics Lead(m/w/x)
Full-timeWith HomeofficeSeniorAachen - Grünenthal GmbH
Global Freight Forwarding Operations & Optimization Manager(m/w/x)
Full-timeWith HomeofficeSeniorAachen