CMC and Regulatory Affairs

9/2019 – 3/2021

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.

Regulatory Affairs

2/2018 – 8/2018

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

Regulatory Affairs

6/2012 – 2/2018

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.

Regulatory Affairs