Regulatory Affairs Freelancer

1/2014 – 10/2017

Roche Diagnostics Rotkreuz, Switzerland: Global Operations Study Department (Investigator Initiated Studies) Coordinating internal study protocol approval workflows for material support and grant payments
Vifor Pharma Glattbrugg, Switzerland: Labelling
Acino Pharma Aesch, Switzerland: RA Change control

Regulatory Affairs

3/2013 – 1/2014

Monitoring global variation projects for Abbott HQ Basel + Interims RA Management for Abbott Swiss
Affiliate.
Abbott HQ Basel responsibilities: EMEA, Middle East, Africa, APAC, LATAM countries
- Monitor actual vs. planned global variation activities and timelines and identify issues impacting project progression (83 countries, 15 drug products)
- Assist with the preparation and review of technical regulatory documentation for agency Submission
- Seeks expert advice and technical support to complete packages
- Responsible for ensuring accuracy and quality of documentation (compliance)
- Maintained working relationships with affiliates in defined countries and provides support for the assigned activities
Abbott Switzerland: In parallel with the HQ role provided support to Swiss affiliate, ensuring high priority submissions, planning of new launches, indication extensions, CMC variations as well as packaging and labeling changes to be notified to the Swiss Authority on time / Regulatory Authority Inspection preparation support

Regulatory Affairs

11/2010 – 3/2013

Position as single point of contact for Notifications of Clinical Trials conducted in Switzerland
• Notification of clinical trials at the Swiss Healthcare Authority Swissmedic
• Provide regulatory advice and guidance to Clinical Operations to ensure compliance with regulations and requirements
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
• Adaptation of notification dossiers to local regulatory requirements
• Submission of change requests, notification of amendments
• Single point of contact for any interaction and questions from authorities
• Release of clinical trial labelling
• Coordination and close cooperation with Intl. Regulatory Affairs
• Improvement of local processes
• Create GCP expertise with focus on Switzerland as also on the basis of EU-ICH Guidelines
• Preparation for Inspection by the Regulatory Authority
Review of drug information texts for drug products with marketing authorization in Switzerland, particularly handling of the publication of drug information in Documed (electronic compendium for drug information, resp. information for healthcare professionals).

Regulatory Affairs, Klinische Forschung, Medizinforschung, Kooperationen, Marketing, UNCLASSIFIED

12/2008 – 9/2010

Coordination and monitoring of generic drugs applications:
• Maintenance submissions (e.g. variations, license renewals), line extensions
• Creation and release of packaging materials
• Proofreading, release and publication of information for professionals and patient information
• Introduction of new drugs in collaboration with Marketing and Sales
• Maintaining contacts with customers, institutions and authorities (Swissmedic, BAG - Federal Health Authority)

Regulatory Affairs, UNCLASSIFIED

12/2007 – 9/2008

Method validation: new diagnostic Test-Kit for preventive care screening for genetic metabolic diseases on the request of PerkinElmer; routine analysis
• Quantitative determination of clinically significant amino acids and acylcarnitines, detecting more than 30 different metabolic diseases using the MS/MS tandem mass spectrometer

Medizinforschung

9/2006 – 9/2007

Business Unit Bioanalytics (data analysis and QC):
• Raw data quality control / presenting final results for sponsor reports for different bioanalytical, pre-clinical study designs

Medizinforschung

1/2000 – 3/2005

Development and implementation of a new product segment in the area of quality assurance for clinical toxicology and forensic laboratories on the basis of analytical reference materials as well as a wide-ranged proficiency testing system for inter-laboratory tests.
Successful development and implementation of a QM system (ISO 9001:2000).
Developed products and services:
• Certified reference controls for drugs of abuse and therapeutic drug monitoring
• Proficiency test materials for the following professional associations:
German Society for Clinical Chemistry, Society for Toxicological and Forensic Chemistry
French Society for Toxicological Analysis, Swiss Center for Quality Control
• Proficiency testing scheme development and implementation:
Society for Toxicological and Forensic Chemistry, Germany

Medizinforschung

10/1995 – 9/1996

Identification, classification, and characterization of microbiological species
• Medical bacteriology, mycology, parasitology
• Clinical virology, immunology

Medizinforschung

10/1994 – 9/1995

Institute of Pathology and Histology
• Tissues sectioning, fixation, embedding, microtome cutting and staining
• Creation of immunohistochemical preparations, In-situ hybridization
• Autopsy assistance

Medizinforschung

2/1990 – 9/1994

IVD Manufacturing assistance for in-vitro diagnostics

Medizinforschung