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Regulatory Affairs Freelancer

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  • Schweiz
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  • 09.07.2021

Kurzvorstellung

Specialising in driving compliance and quality assurance in competitive international pharma and medical sectors through proactive problem-solving and product management capabilities .
Commercially astute with expansive knowledge of RA guidelines .

Qualifikationen

  • Application lifecycle management (ALM)
  • Clinical Trials
  • Compliance management
  • Data Bases, RIMS, EDQMS, LIMS
  • Data Management
  • Documentation filing and tracking
  • eCTD submissions
  • in-vitro Diagnostica
  • Regulatory Affairs Management
  • Variations

Projekt‐ & Berufserfahrung

Regulatory Affairs Consultant (Freelancer)
Parexel International, Remote
8/2018 – 12/2019 (1 Jahr, 5 Monate)
Life Sciences
Tätigkeitszeitraum

8/2018 – 12/2019

Tätigkeitsbeschreibung

Product responsibility for Marketing Authorisations in Switzerland:
- Lifecycle Management (CTAs and post approval maintenace as CMC variations, License Renewals, Artwork changes, PSURs, PSUSAs, Labelling a.o.)

Eingesetzte Qualifikationen

Regulatory Affairs Management

Regaulatory Affairs Contractor (Project Freelancer)
Alexion Pharma AG, Zürich
8/2018 – 4/2019 (9 Monate)
Life Sciences
Tätigkeitszeitraum

8/2018 – 4/2019

Tätigkeitsbeschreibung

RIMS project support , Data Management, Data Migration (electronically published regulatory submission documents)

Eingesetzte Qualifikationen

Regulatory Affairs Management

Regulatory Affairs Associate (Festanstellung)
PaxVax Berna GmbH, Switzerland
11/2017 – 7/2019 (1 Jahr, 9 Monate)
Life Sciences
Tätigkeitszeitraum

11/2017 – 7/2019

Tätigkeitsbeschreibung

- RA submissions and maintenance EU, Asia, Switzerland (MAA, Variations, PSURs, Renewals, Artwork and Labelling Changes)
- Product responsibility Agrippal, Fluad (seasonal flu vaccines)
- Close interaction with RA Global to ensure scalable processes are established
- Submission planning, filing and tracking
- Answering Health Authority inquiries according to timeline
- Managing operational interactions with authorities and vendors
- Process review, SOP updates, budgeting

Eingesetzte Qualifikationen

Regulatory Affairs Management

Regulatory Affairs Freelancer
Roche, Vifor, Acino, Zürich, Zug, Rotkreuz
1/2014 – 10/2017 (3 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

1/2014 – 10/2017

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Regulatory Affairs Management

Regulatory Affairs Manager (Freelance Project)
Abbott AG (Established Pharmaceutical Development), Basel
3/2013 – 1/2014 (11 Monate)
Life Sciences
Tätigkeitszeitraum

3/2013 – 1/2014

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Regulatory Affairs Management

Regulatory Affairs Associate (Festanstellung)
Amgen Switzerland AG, Zug
11/2010 – 3/2013 (2 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

11/2010 – 3/2013

Tätigkeitsbeschreibung

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).

Eingesetzte Qualifikationen

Regulatory Affairs Management, Klinische Studie, Medizinforschung, Kooperationen, Marketing (allg.), Gesundheit (allg.)

Regulatory Affairs Associate (Festanstellung)
Streuli Pharmaceuticals AG, Switzerland, Uznach
12/2008 – 9/2010 (1 Jahr, 10 Monate)
Life Sciences
Tätigkeitszeitraum

12/2008 – 9/2010

Tätigkeitsbeschreibung

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)

Eingesetzte Qualifikationen

Regulatory Affairs Management, Gesundheit (allg.)

Validation Technician (Festanstellung)
Zürich Pediatric Hospital, Zürich
12/2007 – 9/2008 (10 Monate)
Life Sciences
Tätigkeitszeitraum

12/2007 – 9/2008

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Medizinforschung

Quality Control Assistant
CRO - RCC Ltd. (today Harlan Laboratories Ltd.), S, Itingen
9/2006 – 9/2007 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

9/2006 – 9/2007

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Medizinforschung

In-vitro Diagnostica Product Manager (Festanstellung)
Medichem Diagnostics GmbH, Germany, Steinenbronn
1/2000 – 3/2005 (5 Jahre, 3 Monate)
Life Sciences
Tätigkeitszeitraum

1/2000 – 3/2005

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Medizinforschung

Microbiology Lab Technician (Festanstellung)
Synlab Laboratories, Germany, Leinfelden-Echterdingen
10/1995 – 9/1996 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

10/1995 – 9/1996

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Medizinforschung

Histology Lab Technician (Festanstellung)
Marien Hospital Stuttgart, Germany, Stuttgart
10/1994 – 9/1995 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

10/1994 – 9/1995

Tätigkeitsbeschreibung

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

Eingesetzte Qualifikationen

Medizinforschung

Laboratory Assistant (Festanstellung)
Medichem Diagnostics GmbH, Germany, Stuttgart
2/1990 – 9/1994 (4 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

2/1990 – 9/1994

Tätigkeitsbeschreibung

IVD Manufacturing assistance for in-vitro diagnostics

Eingesetzte Qualifikationen

Medizinforschung

Zertifikate

e-Submissions: eAF, CESP, eCTD, eCTD-Baseline, harmonized IT Systems, ISO IDMP, HL7, RPS, eCTD 4.0 (Forum Institute Heidelberg)
2016
CMC Documentation & Post-Approval Changes/Variations (Forum Institute Heidelberg)
2016
Investigator Initiated Studies (Forum Institute Heidelberg)
2014
Regulatory Affairs in ASIA (International intensive course, Forum Management Institute Heidelberg: current regulation framework in Asian countries, ASEAN: Harmonization of the Asian drug market, China: guidelines and MA, MA for Biomaterial Science, Transducers and related electronics in BME, introduction to artificial organs)
2013
EU Regulatory Affairs Training: (Forum Management Institute Heidelberg) EU regulatory guidelines, national guidelines and requirements, application procedures CP/DCP/MRP, variations regulations Typ 1A/B, Typ II, extensions, CMC and quality variations, pediatric regulations, IP, patents, application dossier, eCTD, CCDT, SmPc, regulatory strategy, approval and exceptional circumstances, variation regulation/pharma package in Centralized Procedure, MA in USA, FDA Drug Registration, master file procedure, CEP, IMPD, CTD Module 3)
2013
Regulatory Affairs Management (Clinipace Ltd., Zürich)
2012
Project management; project planning, emotional intelligence
2011
GCP Inspections (Swissmedic), GCP (Clinipace, Zürich)
2011
Notification for authorization of drugs for veterinary medicine (Swiss Healthcare Authority Swissmedic, Bern - Switzerland)
2009
Drug labeling, information and packaging requirements (Forum Institute, Germany)
2009
Certificate
1994

Ausbildung

Medical Laboratory Technician (MLT)
Ausbildung
1994
Esslingen am Neckar

Über mich

Specialising in driving compliance and quality assurance in competitive international pharma and medical sectors through proactive problem-solving and product management capabilities .
Commercially astute with expansive knowledge of RA guidelines and documentation requirements across EU, CH and International regions.
Cross-cultural strong diplomatic skills & sensitive to different management styles.

Weitere Kenntnisse

- 10 years Regulatory Affairs experience
- Regulatory Affairs submissions, Lifecycle Management, eCTD, technical files publishing and maintenance: e.g. CMC Variations, Renewals, Certificates, License Renewals, CTA, PSURS, PSUSAs, Artwork, labelling, promotional material
- Data Management, Tracking, RIMS, EDQM
- RA Guidelines and documentation requirements EU, CH and International
- Notification of Clinical Trials in Switzerland
- Quality Assurance, QM, ISO, DIN EN 17025, DIN EN 13485, IVD 98/79/EG
- EU-ICH Guidelines, GxP

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Gut)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
4147
Berufserfahrung
33 Jahre und 5 Monate (seit 10/1990)
Projektleitung
5 Jahre

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