freiberufler CMC and Regulatory Affairs auf freelance.de

CMC and Regulatory Affairs

offline
  • auf Anfrage
  • 34128 Kassel
  • Weltweit
  • sd  |  en  |  de
  • 31.03.2021

Kurzvorstellung

I have been working in Pharmaceutical Industry. I possess experience of CMC, dossier writing, preparation of quality part of dossiers. Modules 1, 2 and 3 of CTD. Registration in EU, middle east and most part of Asia, knowledge of medicinal devices.

Qualifikationen

  • Regulatory Affairs Management

Projekt‐ & Berufserfahrung

CMC Scientiffic Writer
Galderma Switzerland, Schweiz
9/2019 – 3/2021 (1 Jahr, 7 Monate)
Gesundheitswesen
Tätigkeitszeitraum

9/2019 – 3/2021

Tätigkeitsbeschreibung

Writing CMC parts (module 2, module 3 for drug substance and drug product) for world-wide registrations including (but not limited to) Europe, FDA, Asia, Middle East, Africa, Latin America, Australia. Update dossiers from quality documents, update dossiers for variations, responses to list of questions, preparation of documents for briefing meetings and other meetings with authorities.
Update of quality dossiers for worldwide variations.

Eingesetzte Qualifikationen

Regulatory Affairs Management

Consultant Regulatory Affairs
Woodley Bioreg, Huddersfield
2/2018 – 8/2018 (7 Monate)
Dienstleistungsbranchen (Service)
Tätigkeitszeitraum

2/2018 – 8/2018

Tätigkeitsbeschreibung

Support in registration activities for clients in pharmaceutical registrations, variations as well as registration of Medical devices.

Eingesetzte Qualifikationen

Regulatory Affairs Management

Senior Regulatory Affairs Manager (Festanstellung)
Bremer Pharma GmbH, Warburg
6/2012 – 2/2018 (5 Jahre, 9 Monate)
Gesundheitswesen
Tätigkeitszeitraum

6/2012 – 2/2018

Tätigkeitsbeschreibung

Preparation of module 1, module 2, and module 3, on the basis of raw data. New product development, preparation of GMP inspections, training of staff.
Managing CMC documents
Contributing to the timely regulatory approval
Support the development and QC of the regulatory strategy to ensure cross-functional alignment
Electronic submission with CESP/EUDRAlink
Submission of new applications for procedure of national, MRPs.
Administration of over 50 EU registrations, and world-wide more than 300 registrations.
Communication with EU and other authorities in all fields of regulatory affairs.
Evaluation of pharmacovigilance documents, PSURs, adverse reactions.
Strategy for development of generic applications, product development, regulatory requirements for product development.
Change control process.
Budget management for regulatory affairs, product development.
Information manager according to German law – controlling labels and other information.
Deputy Qualified Person for Pharmacovigilance (Deputy QPPV), according to EU regulations.
Preparation of SOPs for regulatory affairs.

Eingesetzte Qualifikationen

Regulatory Affairs Management

Ausbildung

Chemistry
PhD
2005
Mainz

Über mich

I have been working in Pharmaceutical Industry. I possess experience of CMC, dossier writing, preparation of quality part of dossiers. Modules 1, 2 and 3 of CTD. Registration in EU, middle east and most part of Asia, knowledge of medicinal devices directives and registration process in various regions.

Weitere Kenntnisse

PhD in Chemistry, training in CMC documentation, variations, pharmacovigilance, life cycle management

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Deutsch (Gut)
  • Sindhi (Muttersprache)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
1054
Alter
49
Berufserfahrung
18 Jahre und 6 Monate (seit 09/2005)
Projektleitung
6 Jahre

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