Expert Regulatory Affairs CMC Biologics

• Jul 2023 - Present

Global Regulatory CMC Intern

• Oct 2022 - Mar 2023

Completed seven pieces of training to become CTIS administrator by Bayer’s CTIS Mastertrainer Worked closely with the submission teams of Bayer‘s EU-CTR pilot trials Project thesis: new portal CTIS to upload clinical trial applications and its impact on the preparation of registration dossiers : - detailed presentation of the portal and it’s functions -evaluated the operative changes, e.g. redaction of information, new IMPD structure and timelines Completed seven pieces of training to become CTIS administrator by Bayer’s CTIS Mastertrainer Worked closely with the submission teams of Bayer‘s EU-CTR pilot trials Project thesis: new portal CTIS to upload clinical trial applications and its impact on the preparation of registration dossiers : - detailed presentation of the portal and it’s functions -evaluated the operative changes, e.g. redaction of information, new IMPD structure and timelines

Intern Oncology

• Apr 2022 - Sep 2022

- Support in the Assessment of Module 3 in several DCPs in various stages according to ICH / EMA guidelines - authoring of assessement reports (Day 70 / Day 120) - Handling of Type Ia, Ib and II Variations -Preperation and participation in scientific advices and presubmission meetings - Support in the Assessment of Module 3 in several DCPs in various stages according to ICH / EMA guidelines - authoring of assessement reports (Day 70 / Day 120) - Handling of Type Ia, Ib and II Variations -Preperation and participation in scientific advices and presubmission meetings

Student Trainee Regulatory Affairs / Quality

• Jun 2021 - Mar 2022

Regulatory activities: - Support in the development of a regulatory strategy for EMA,FDA and TGA for a new product in an international project team - Preparation of Module 3.2.S. in the eCTD format for a MAA - Contribution to raw material assessment - Verification of stability data Quality activities: - Management of the transition from global specifications to local SOPs and subsequent CAPA management in a GMP controlled enviroment -Data base management - Updating of existing SOPs - Preparation of documents for an internal audit General activities: - Creation of PowerPoint presentations Show less

Research Consultant

• Oct 2018 - Mar 2019

- Project and team-based research work in given targets with focus on regulatory affairs jobs - Identification, contact and approach of candidates as well as the presentation of the vacant position with a subsequent suitability assessment - Documentation of the results via Microsoft Excel, as well as a following evaluation with the respective project manager. - Project and team-based research work in given targets with focus on regulatory affairs jobs - Identification, contact and approach of candidates as well as the presentation of the vacant position with a subsequent suitability assessment - Documentation of the results via Microsoft Excel, as well as a following evaluation with the respective project manager.