Pharma Support & Advisor ? Technical Regulatory & Quality Assurance
Aktualisiert am 29.05.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 17.05.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Technical Regulatory
Quality Assurance
Pharma Life Science
siehe Kompetenzen
German
native
English
fluent

Einsatzorte

Einsatzorte

Freiburg im Breisgau (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 Jahr 10 Monate
2024-08 - heute

Pharma Support & Advisor

Pharma Support & Advisor - Technical Regulatory & Quality Assurance
Pharma Support & Advisor - Technical Regulatory & Quality Assurance

Aus- und Weiterbildung

Aus- und Weiterbildung

1994 - 1998

Organic, Inorganic, Bio and Physical Chemistry

Diploma

Albert-Ludwigs-University Freiburg im Breisgau


Key Focus:

Dissertation: on request

Position

Position

Pharma Support & Advisor - Technical Regulatory CMC & Quality Assurance

Kompetenzen

Kompetenzen

Top-Skills

Technical Regulatory Quality Assurance Pharma Life Science siehe Kompetenzen

Produkte / Standards / Erfahrungen / Methoden

Technical Regulatory
Experte
QA for QC
Experte

Profile

Based on my 25 years experience I am offering agile and hands on support for technical regulatory or quality assurance projects: CMC submissions & life-cycle, global compliance for chemical and biological drug substances and products. QA support for internal or global multidisciplinary interfaces from external suppliers, goods receipt, warehousing, QA for QC, sampling, release, and documentation management. Due diligence, governance, Deviation, CAPA and Change Management. Experienced in cross-functional collaboration, maintaining GXP compliance and implementing risk-based approaches. Strong reliable partner and communicator with analytical mind-set, passion for your excellence.

Core Competencies:

·   Regulatory Affairs CMC: Global IND/IMPD, NDA/MAA (CTD), change management, renewals, site transfers

·   Quality Assurance: cGMP/GLP/GDP compliance, DevMan, CAPA, change control, authoring/review of SOPs, guidelines and directives, onboarding & training profiles, auditing & inspection support

·   By Request: Leadership & coaching, mentoring, personal & team development, performance management

·   Project & stakeholder management: Project management, cross-functional and global teams, exchange & networking

Soft Skills: Integrity, reliability, analytical thinking, effective communication, issue-solving, business acumen

Branchen

Branchen

Pharma

Einsatzorte

Einsatzorte

Freiburg im Breisgau (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 Jahr 10 Monate
2024-08 - heute

Pharma Support & Advisor

Pharma Support & Advisor - Technical Regulatory & Quality Assurance
Pharma Support & Advisor - Technical Regulatory & Quality Assurance

Aus- und Weiterbildung

Aus- und Weiterbildung

1994 - 1998

Organic, Inorganic, Bio and Physical Chemistry

Diploma

Albert-Ludwigs-University Freiburg im Breisgau


Key Focus:

Dissertation: on request

Position

Position

Pharma Support & Advisor - Technical Regulatory CMC & Quality Assurance

Kompetenzen

Kompetenzen

Top-Skills

Technical Regulatory Quality Assurance Pharma Life Science siehe Kompetenzen

Produkte / Standards / Erfahrungen / Methoden

Technical Regulatory
Experte
QA for QC
Experte

Profile

Based on my 25 years experience I am offering agile and hands on support for technical regulatory or quality assurance projects: CMC submissions & life-cycle, global compliance for chemical and biological drug substances and products. QA support for internal or global multidisciplinary interfaces from external suppliers, goods receipt, warehousing, QA for QC, sampling, release, and documentation management. Due diligence, governance, Deviation, CAPA and Change Management. Experienced in cross-functional collaboration, maintaining GXP compliance and implementing risk-based approaches. Strong reliable partner and communicator with analytical mind-set, passion for your excellence.

Core Competencies:

·   Regulatory Affairs CMC: Global IND/IMPD, NDA/MAA (CTD), change management, renewals, site transfers

·   Quality Assurance: cGMP/GLP/GDP compliance, DevMan, CAPA, change control, authoring/review of SOPs, guidelines and directives, onboarding & training profiles, auditing & inspection support

·   By Request: Leadership & coaching, mentoring, personal & team development, performance management

·   Project & stakeholder management: Project management, cross-functional and global teams, exchange & networking

Soft Skills: Integrity, reliability, analytical thinking, effective communication, issue-solving, business acumen

Branchen

Branchen

Pharma

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