freiberufler Consultant Regulatory Affairs Management + Drug Safety Information Management auf freelance.de

Consultant Regulatory Affairs Management + Drug Safety Information Management

offline
  • auf Anfrage
  • Nordrhein-Westfalen
  • Weltweit
  • de  |  en
  • 27.05.2024

Kurzvorstellung

16 y Drug Regulatory Affairs (Senior Manager)
3 m Regulatory Affairs Medical Devices (Junior Manager)
2 y Drug Safety Information Management (Signal Management)

Countries: EU, CIS, CEFTA, APAC, MEA, LATAM, USA, CAN
full-time/part-time
on site/remote

Qualifikationen

  • Budgetierung3 J.
  • Change-Request-Management4 J.
  • Change Management11 J.
  • Compliance management13 J.
  • Dokumentenmanagement4 J.
  • Interim Management9 J.
  • Interkulturelle Kommunikation6 J.
  • Lifecycle Management13 J.
  • Pharmazie14 J.
  • Produktmanagement7 J.
  • Projektdurchführung12 J.
  • Regulatory Affairs14 J.
  • Software Asset Management13 J.
  • Technische Dokumentation
  • Unternehmensberatung9 J.
  • Workflows14 J.

Projekt‐ & Berufserfahrung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, München
4/2023 – offen (1 Jahr, 9 Monate)
Pharma
Tätigkeitszeitraum

4/2023 – offen

Tätigkeitsbeschreibung

Complex variations (Quality + Safety), worksharing, renewals, PASS protocol and PSUR submissions
- Submission Management
- Change Control Management
- Labeling: Adaptation of EU product information texts (M 131)
- Updated CTD Modules 1, 2 and 3 documentation
- Database maintenance /Document management
- Application for CPPs and other administrative documents
- Budgeting and initiating payments
- Interface function (CMOs, QM, QC, QA, Supply Chain)

Countries: EEA: DE, ES, IT, FR, PT, NL + China +Switzerland

Eingesetzte Qualifikationen

Budgetierung, Change-Request-Management, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Pharmazie, Lifecycle Management, Produktmanagement, Projektdurchführung, Workflows, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, Nürnberg
12/2021 – 12/2022 (1 Jahr, 1 Monat)
Pharmahersteller
Tätigkeitszeitraum

12/2021 – 12/2022

Tätigkeitsbeschreibung

- Generic German new applications + maintenance/LCM of existing MAs
- Preparation for product launches (launch relevant change notifications)
- Labeling: Creation and adaptation of German product information texts (M 131)
- Labeling: Originator text updates
- Administrative, CMC and Safety variations
- Submission planning and database maintenance
- Change Control Management
- Close cooperation with sales partners/ CMOs and Specialist departments (CMC, Artwork, Supply Chain, Quality Assurance, Reg. Operations/Publishing)

Eingesetzte Qualifikationen

Change-Request-Management, Change Management, Compliance management, Interim Management, Software Asset Management, Pharmazie, Lifecycle Management, Produktmanagement, Projektdurchführung, Workflows, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, Strausberg
11/2021 – 11/2021 (1 Monat)
Pharmahersteller
Tätigkeitszeitraum

11/2021 – 11/2021

Tätigkeitsbeschreibung

- Preparation of regulatory expert reports on the business development/diligence process
- Dossier audit

Eingesetzte Qualifikationen

Medizinforschung, Medizin, Business Development, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Klinische Forschung, Software Asset Management, Pharmazie, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, Marburg
4/2021 – 3/2022 (1 Jahr)
Pharmahersteller
Tätigkeitszeitraum

4/2021 – 3/2022

Tätigkeitsbeschreibung

- Document Management
- Submissionmanagement + Tracking of regulatory activities (variations, renewals, responses, PSUR/PBRER, CCDS/CCSI updates)
- creation/update of CTD Module 1 documentation
- tight collaboration with mit Senior Managers, Affiliates, Distributors and Special departments (CMC, Labelling, Reg. Operations, Publishing)

Countries: entire EEA + Switzerland + UK

Eingesetzte Qualifikationen

Dokumentenmanagement, Interim Management, Pharmazie, Lifecycle Management, Workflows, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs / EU Regulatory Lead
Kundenname anonymisiert, Wien + Zug
11/2019 – 12/2020 (1 Jahr, 2 Monate)
Pharmahersteller
Tätigkeitszeitraum

11/2019 – 12/2020

Tätigkeitsbeschreibung

EU Regulatory Strategy Lead
Regulatory Affairs Magement EU MAs (MRP/DCP/CP), MAs in Israel, Palestine and Balkan countries
Consulting in RA Strategy +LCM, planning, submission, implementation and follow up

Eingesetzte Qualifikationen

Interim Management, Software Asset Management, Pharmazie, Lifecycle Management, Produktmanagement, Projektdurchführung, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs + Drug Safety Information Management
Kundenname anonymisiert, Sulzbach
10/2019 – 6/2021 (1 Jahr, 9 Monate)
Pharmahersteller
Tätigkeitszeitraum

10/2019 – 6/2021

Tätigkeitsbeschreibung

Regulatory Affairs Consultant for German Marketing Authorizations +
Drug Safety Information Management Consultant / Deputy RPPV (Stufenplanbeauftragter)
Medical/Drug Safety Information Management:
- PV signal management / signal detection and analysis
- Evaluation of side effects and safety signals + follow-up process
- PV database maintenance and data entry in ARISg
- Retrieve adverse event cases from EudraVigilance
- MedDRA coding of side effects
- Literature screening/monitoring of scientific journals
- Monthly reconciliation of side effect cases

Regulatory Affairs:
- Submission of variations/responses, renewals and product line extensions for MAs registered in Germany
- Labeling: Adaptation/harmonization of German product information texts based on CCSI/CCDS updates
- Creation/update of the CTD Module 1 documentation
- Submission management (CESP and PharmNet.Bund)
- CMC compliance
- Close cooperation with headquarters, product management, QPPV, global labeling, Rote Liste and Lauer Taxe

Eingesetzte Qualifikationen

Medizin, Pharmazie, Compliance management, Interim Management, Software Asset Management, Lifecycle Management, Produktmanagement, Projektdurchführung, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, Paris
3/2018 – 8/2019 (1 Jahr, 6 Monate)
Pharmahersteller
Tätigkeitszeitraum

3/2018 – 8/2019

Tätigkeitsbeschreibung

Worldwide Regulatory Affairs Management of one product (contrast agent, different stengths and presentations).
APAC, Canada, CIS, EU, LATAM, MENA, OZEANIA, USA (over 80 countries)
Strategy
Planning, coordination and execution of post approval acticities (variations + renewals)
New Registrations + Line Extensions
Temporary Authorizations
Preparation of regulatory statements for global projects and submissions
Providing supporting information and documentation for marketing, pharmacovigilance and GMP inspections
Database maintenance and publishing
Interface function

Eingesetzte Qualifikationen

Pharmazie, Change-Request-Management, Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Lifecycle Management, Produktmanagement, Projektdurchführung, Workflows, Regulatory Affairs, Unternehmensberatung

Regulatory Affairs Manager (Festanstellung)
Kundenname anonymisiert, Holzkirchen
11/2017 – 2/2018 (4 Monate)
Pharmahersteller
Tätigkeitszeitraum

11/2017 – 2/2018

Tätigkeitsbeschreibung

Regulatory Affairs Management of Generic Products of 35 Active Substances
- Expert advice on submission strategies
- Planning, coordination and implementation of RA projects
- Management of post-approval activities
- Ensuring regulatory compliance (dossier and product information)
- Initiation of RMS (Reference Member State) changes
- Close collaboration with execution managers, regulatory maintenance centers (CMC team), stakeholders and specialist departments, contact with authorities

Eingesetzte Qualifikationen

Projektdurchführung, Lifecycle Management, Software Asset Management, Regulatory Affairs

Freelance Consultant Drug Regulatory Affairs + CMC Specialist
Kundenname anonymisiert, Bad Ems
6/2017 – 9/2017 (4 Monate)
Pharmaindustrie
Tätigkeitszeitraum

6/2017 – 9/2017

Tätigkeitsbeschreibung

Product Group: Medicinal Teas

Tasks:
- CMC Life Cycle Management (national DACH)
• CMC related variations regarding Active Substances and Finished Products (e.g. changes in analytical procedures)
• Preparation of documentation for CH (Swissmedic) requirements (e.g. manufacturer information, conformity declarations etc.)
• Preparation of documentation for renewals
- Updating of CTD documentation (M2+M3)
- eSubmissions via CESP (Common European Submission Portal)
- Preparation of registration documents for export projects
- GAP-analysis - GAP-analysis (comparison of specifications and analytical procedures with Ph. Eur. monographs)

Countries:
DACH region: Entire
CIS: Russia
MEA: Iran
APAC: Malaysia

Eingesetzte Qualifikationen

Naturheilkunde, Pharmazie, Compliance management, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Projektdurchführung, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs + CMC-Specialist
Kundenname anonymisiert, Hennef
2/2016 – 4/2017 (1 Jahr, 3 Monate)
Pharmaindustrie
Tätigkeitszeitraum

2/2016 – 4/2017

Tätigkeitsbeschreibung

Product Groups: Nonionic X-ray contrast media, contrast media for magnetic resonance imaging

- Expert advice and regulatory support for questions with CMC content for Finished Products and Active Substances
- Transfer of Marketing Authorisations (national MAs, CP, DCP, MRP) to a new MAH
- Preparation, fee calculation, submission and tracking of variations (national, CP, DCP, MRP) and
responses to deficiency letters to:
a) CMC related changes
b) Administrative changes
c) Labelling related changes
d) Drug Safety related changes
- eSubmissions
- CTD Update
- Preparation documents with CMC content for new registration applications
- Support for submissions of PSURs / PBRERs for a Centralized Procedure
- Submission of Responses to PRAC questions regarding an Article 20 Referral procedure
close collaboration with QC and Global RA in U.S. Headquarter, publishing and labelling team and local RA contacts in EU.

Countries:
EEA: Entire
EU-ROW: Switzerland
CIS + CEFTA countries: Russia, Ukraine; Bosnia-Herzegovina, Serbia
MEA: Botswana, Namibia, Turkey, South Africa
USA + Canada

Eingesetzte Qualifikationen

Pharmazie, Budgetierung, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Lifecycle Management, Projektdurchführung, Workflows, Regulatory Affairs, Unternehmensberatung

Freelance Consultant CMC-Compliance (Drug Regulatory Affairs)
Kundenname anonymisiert, Basel
11/2015 – 12/2015 (2 Monate)
Pharmaindustrie
Tätigkeitszeitraum

11/2015 – 12/2015

Tätigkeitsbeschreibung

Product Groups:
Chemotherapeutic agent: Tyrosine Kinase Inhibitor (Rx); Immunosuppressant: Monoclonal Antibody (Rx)

Tasks: GAP-Analyses
CMC document review and GAP-analysis GAP between GMP/technical documents and regulatory CTD dossier M3

Eingesetzte Qualifikationen

Compliance management, Good Manufacturing Practices, Interim Management, Software Asset Management, Pharmazie, Projektdurchführung, Regulatory Affairs, Technische Dokumentation, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs
Kundenname anonymisiert, Darmstadt
8/2015 – 10/2015 (3 Monate)
Pharmaindustrie
Tätigkeitszeitraum

8/2015 – 10/2015

Tätigkeitsbeschreibung

Product Groups: Thyrostatic substance (Rx)

Tasks:
CMC-Life-Cycle-Management
Preparation for Tech-Transfers
GAP-Analysis

Eingesetzte Qualifikationen

Pharmazie, Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Lifecycle Management, Projektdurchführung, Regulatory Affairs, Unternehmensberatung

Freelance Consultant Drug Regulatory Affairs / Global CMC Specialist
Kundenname anonymisiert, Limburg
2/2015 – 8/2015 (7 Monate)
Pharmaindustrie
Tätigkeitszeitraum

2/2015 – 8/2015

Tätigkeitsbeschreibung

Product Groups: Antiseptics (OTC) and Opioids (Rx)

Tasks:
- CMC Life Cycle Management (global-national Emerging Markets and MRP)
- Preparation and submission of complex CMC variations
- CTD update
- Change Control Management
- Close collaboration with local RA contacts, technical writer, strategy team, manufacturer, quality assurance and regulatory operations & publishing team

Countries:
EEA: Entire
EU-ROW: Switzerland
APAC: China, Hong Kong, Indonesia, Korea, Malaysia, Myanmar, Philippines, Singapore, Taiwan, Thailand, Vietnam
MEA: Bahrain, Jordan, Kenya, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, Uganda, United Arab Emirates

Eingesetzte Qualifikationen

Pharmazie, Change-Request-Management, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Interkulturelle Kommunikation, Software Asset Management, Lifecycle Management, Workflows, Regulatory Affairs, Unternehmensberatung

Global Regulatory Affairs Manager (Festanstellung)
Kundenname anonymisiert, Haan, Monheim
7/2012 – 12/2013 (1 Jahr, 6 Monate)
Consultant; Pharmaindustrie
Tätigkeitszeitraum

7/2012 – 12/2013

Tätigkeitsbeschreibung

Product Groups:
ACE-Inhibitors (Rx); Iron-combined preparations (OTC)

Countries:
EEA: Entire
EU-ROW: Switzerland, Turkey
CIS: Ukraine, Russia
ROW: Algeria, China, Jordan, Korea, Mexico, Pakistan, Peru, Philippines, Venezuela, United Arab Emirates

Tasks:
- CMC-relevant collaboration in national drug approval in China and Spain
- CTD-update after admission
- CMC Life-Cycle-Management (Variations, Renewals)
- Variation-classification, preparation of variation-declarations, compilation of the documents to be submitted, scheduling and filing of documents, processing of additional demands and deficiency letters, follow-up and closure of proceedings
- Change Control Management (regular attendance in change control board)
- GAP- analysis of module 3 dossier
- Administration of renewal procedures in line with CMDh-Guideline
- Updating of product information according to CCDS review
- Execution of a global product recall (member of recall execution team)
- Preparation of xEVMPD-relevant data
- SOP-Review
- Development of an approach for a regulatory strategy regarding product expansion in EU and ROW
- Supportive work for inquiries regarding PSUR and U.S. PADER
- Supportive work for Annual Product Quality Review (PQR)
- Review of Annual Stability Batch Programs
- Cross-product-implementation of PSMF
- Internal workshops and product presentations
- Shadowing-process
- Close collaboration with locally based regulatory affairs managers, manufacturer, quality assurance, supply chain, pharmacovigilance, regulatory operations & publishing team and medical advisor

Eingesetzte Qualifikationen

Pharmazie, Business Development, Change Management, Compliance management, Interkulturelle Kommunikation, Software Asset Management, Lifecycle Management, Produktmanagement, Workflows, Qualitätsmanagement (allg.), Regulatory Affairs, Schulung / Coaching (allg.)

Scientific Employee, Drug Licensing (Procedural Management) - Drug Regulatory Affairs (Festanstellung)
Kundenname anonymisiert, Bonn
3/2009 – 7/2012 (3 Jahre, 5 Monate)
Öffentliche Verwaltung
Tätigkeitszeitraum

3/2009 – 7/2012

Tätigkeitsbeschreibung

Product Groups:
Phytopharmaceuticals, homeopathic medicinal products and traditional herbal medicinal products, vitamins, minerals, healing waters

Tasks:
- Scientific administration of European MA procedures (MRP, DCP, RUP), variations, renewals and variations in line with §29 AMG
- Coordination of referral-procedures in line with Art. 31 der Dir. 2001/837EC
- Scientific validation of national applications for marketing authorization
- Content-related processing and plausibility check of the fulfillment of the conditions for renewal in line with § 31 AMG and reregistration in line with § 105 AMG
- Professional support for the project assistance (two project officers)
- Correspondence between pharmaceutical entrepreneur and assessors for CTD-modules 3, 4 and 5
- EU-wide correspondence with competent authorities for medicinal products
- Processing and answering to requests
- Review of SOP’s
- Preparation of the monthly statistics

Special Project:
- Scientific coordination, management and maintenance of a knowledge-management-project based on a content-management-systems (WIKI)

Eingesetzte Qualifikationen

Change Management, Compliance management, HTML, Kommunikation (allg.), Software Asset Management, Pharmazie, Lifecycle Management, Projektdurchführung, Projektmanagement, Workflows, Recht (allg.), Regulatory Affairs, Wissensmanagement

Scientific Employee (Narcotics Permission Affairs) (Festanstellung)
Kundenname anonymisiert, Bonn
10/2008 – 12/2008 (3 Monate)
Öffentliche Verwaltung
Tätigkeitszeitraum

10/2008 – 12/2008

Tätigkeitsbeschreibung

- Management of special permissions in line with §3(2) BtMG for medically-supervised self-treatment with medicinal cannabis
- Evaluation of applicant’s documents ( medical reports etc.)
- Management of special permissions for clinical trials on narcotics

Eingesetzte Qualifikationen

UNCLASSIFIED, Klinische Forschung, Medizin, Pharmazie, Projektdurchführung, Projektmanagement

Job Advisor and Recruiter (Festanstellung)
Kundenname anonymisiert, Wuppertal, Witten
4/2002 – 12/2004 (2 Jahre, 9 Monate)
Öffentliche Verwaltung
Tätigkeitszeitraum

4/2002 – 12/2004

Tätigkeitsbeschreibung

- Employer Services

Eingesetzte Qualifikationen

Arbeitsrecht, Arbeitslosengeld, Arbeitsvermittlung, Finanzen (allg.), Kommunikation (allg.), Fusionen und Übernahmen, Personalwesen (allg.), Workflows, Schulung / Coaching (allg.)

Molecular- and Cell Biologist (Festanstellung)
Kundenname anonymisiert, Wuppertal
2/2000 – 6/2001 (1 Jahr, 5 Monate)
Pharmaindustrie
Tätigkeitszeitraum

2/2000 – 6/2001

Tätigkeitsbeschreibung

- Planning and performance of human gene cloning (ion channels, G protein-coupled receptors etc.) from c-DNA library
- Construction and evaluation of eucaryotic constitutive and inducible expression systems
- Generating of recombinant cell lines with different transfection methods
- Clone pool analysis
- Pharmakological characterisation of cell lines using the reporter genes luciferase and aequorin
- High Througput Screening
- Vector construction and data evaluation with DNA-Anaysis-Software

Eingesetzte Qualifikationen

Angewandte Forschung, Biologie, Forschung & Entwicklung, Grundlagenforschung, Medizinforschung, Naturwissenschaft

Zertifikate

DGRA workshop on new drug legislation
DGRA
2024
Basic training GMP / advanced training GMP
Concept Heidelberg /GMP Navigator
2022
DGRA workshop “Medical Devices Regulation”
DGRA
2021
Workshop: German Narcotics Act and tasks of the Narcotics Responsible Person
Häußermann Narcotics consulting
2021
The Narcotics Responsible Person in practice
PTS Training Service
2019
The Narcotics Responsible Person – everything about storage, traffic and monitoring of narcotics
FORUM
2019
CMC Specialist
2015
Legal expertise in the retail trade with OTC drugs in line with §50 AMG (German Drug Law)
2014
Quality- and Manufacturing Know-How for Regulatory Affairs/CMC
2014
9. DGRA Schools: Chemical-pharmaceutical documentation (CMC / Module 3)
FORUM
2013

Ausbildung

Manager Regulatory Affairs Medical Devices International (01.02 - 29.04.2024))
Ausbildung
TÜV Rheinland Academy in collaboration with the Ulm University of Technology
2024
Studium der Biologie (Molekularbiologie, Biochemie, Zoologie, Botanik)
Diplom-Biologin (Master)
Universität zu Köln
1999
Köln

Über mich

In-depth knowledge & experience in global drug regulatory affairs management, strategy and regulatory compliance.
Excellent team working and cross-cultural communication skills.
Pragmatic and creative problem solving capabilities.

In April 2024, I completed my training to become Manager Regulatory Affairs for Medical Devices international at the TÜV Rheinland Academy (in collaboration with the Technical University of Ulm) and am now also looking for junior manager projects in the RA Medical Devices area.

Weitere Kenntnisse

Regulatory Affairs Consulting worldwide
Regulatory Affairs Management worldwide

Drug Regulatory Affairs: Senior Manager
Medical Devices Regulatory Affairs: Junior Manager/Entry Level
Drug Safety Information Management (Signal Management): Junior Manager

Licensing Requirements / Strategy
New Drug Application / Post Approval Activities (PAM, Labelling, Safety, Quality)
Submission Management /Administrative Tasks / Databases

QMS / Technical Documentation
MDR / ISO 13485 / ISO 14971 /

Betäubungsmittel Verantwortlicher

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
5098
Berufserfahrung
24 Jahre und 10 Monate (seit 02/2000)

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