Regulatory Affairs Freelancer, Project Associate, Administrative Support

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 13.05.2018

Kurzvorstellung

Seeking a challanging freelance position within Regulatory Affairs for further development.

Ich biete

Forschung, Wissenschaft, Bildung
  • GxP
    1 Jahr, 9 Monate Erfahrung

Projekt‐ & Berufserfahrung

Regulatory Affairs Associate
Kundenname anonymisiert, Switzerland
11/2016 – offen (1 Jahr, 10 Monate)
Life Sciences
Tätigkeitszeitraum

11/2016 – offen

Tätigkeitsbeschreibung

- RA submissions and maintenance EU, Asia, Switzerland (MAA, Variations, PSURs, Renewals, Artwork and Labelling Changes)
- 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

GxP


Regulatory Affairs Contractor
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
Amgen Switzerland AG, Zug, 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

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


Regulatory Affairs Assistant
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 the approval process for generic drugs
• 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.)


Medical Lab Technician
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


Project Management
Medichem Diagnostics GmbH, Germany, Steinenbronn
10/1996 – 3/2005 (8 Jahre, 6 Monate)
Life Sciences
Tätigkeitszeitraum

10/1996 – 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


Medical Laboratory Technician
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


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

2/1990 – 9/1994

Tätigkeitsbeschreibung

Manufacturing assistance for diagnostic reagents

Eingesetzte Qualifikationen

Medizinforschung


Zertifikate

e-Submissions: eAF, CESP, eCTD, eCTD-Baseline, harmonized IT Systems, ISO IDMP, HL7, RPS, eCTD 4.0 (Forum Institute Heidelberg)
April 2016

CMC Documentation & Post-Approval Changes/Variations (Forum Institute Heidelberg)
März 2016

Investigator Initiated Studies (Forum Institute Heidelberg)
Juni 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)
Oktober 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)
Februar 2013

Regulatory Affairs Management (Clinipace Ltd., Zürich)
März 2012

Project management; project planning, emotional intelligence
Mai 2011

GCP Inspections (Swissmedic), GCP (Clinipace, Zürich)
März 2011

Notification for authorization of drugs for veterinary medicine (Swiss Healthcare Authority Swissmedic, Bern - Switzerland)
August 2009

Drug labeling, information and packaging requirements (Forum Institute, Germany)
Mai 2009

Certificate
September 1994

Ausbildung

Medical Laboratory Technician (MLT)
(Ausbildung)
Jahr: 1994
Ort: Esslingen am Neckar

Qualifikationen

- 8 years Regulatory Affairs experience
- Regulatory Affairs Submissions, Maintenance, Life Cycle Management (pharmaceutical drug products), Switzerland
• Notification of Clinical Trials, Switzerland
- Project Management
• QM - ISO
• EU-ICH Guidelines, GxP

Über mich

INTER-PERSONAL SKILLS:
• Reliable with an outstanding sense of duty
• Creative thinking, decision making and problem solving personality
• Ability to effectively manage multiple priorities and tasks
• Strong ability to develop and re-design processes
• Excellent team player with a strong ability also to work independently within international teams
• Ability to effectively manage multiple priorities and tasks
• Strong communication skills, flexibility, enthusiasm for other cultures

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Gut)
  • Französisch (Gut)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
526
Berufserfahrung
27 Jahre und 10 Monate (seit 10/1990)
Projektleitung
5 Jahre

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