Consultant Regulatory Affairs Management + Drug Safety Information Management

4/2021 – 3/2022

- 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

Dokumentenmanagement, Interim Management, Pharmazie, Product-lifecycle-management (PLM), Prozess- / Workflow, Regulatory Affairs Management, Unternehmensberatung

11/2019 – 12/2020

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

Interim Management, Lizenzmanagement, Pharmazie, Product-lifecycle-management (PLM), Produktmanagement, Projektdurchführung, Regulatory Affairs Management, Unternehmensberatung

10/2019 – 6/2021

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

Medizin, Pharmazie, Compliance management, Interim Management, Lizenzmanagement, Product-lifecycle-management (PLM), Produktmanagement, Projektdurchführung, Regulatory Affairs Management, Unternehmensberatung

3/2018 – 8/2019

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

Pharmazie, Change-Request-Management, Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Product-lifecycle-management (PLM), Produktmanagement, Projektdurchführung, Prozess- / Workflow, Regulatory Affairs Management, Unternehmensberatung

11/2017 – 2/2018

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

Projektdurchführung, Product-lifecycle-management (PLM), Lizenzmanagement, Regulatory Affairs Management

6/2017 – 9/2017

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

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

2/2016 – 4/2017

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

Pharmazie, Budgetierung, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Product-lifecycle-management (PLM), Projektdurchführung, Prozess- / Workflow, Regulatory Affairs Management, Unternehmensberatung

11/2015 – 12/2015

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

Compliance management, Gute Herstellungspraxis (GMP), Interim Management, Lizenzmanagement, Pharmazie, Projektdurchführung, Regulatory Affairs Management, Technische Dokumentation, Unternehmensberatung

8/2015 – 10/2015

Product Groups: Thyrostatic substance (Rx)

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

Pharmazie, Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Product-lifecycle-management (PLM), Projektdurchführung, Regulatory Affairs Management, Unternehmensberatung

2/2015 – 8/2015

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

Pharmazie, Change-Request-Management, Change Management, Compliance management, Dokumentenmanagement, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Product-lifecycle-management (PLM), Prozess- / Workflow, Regulatory Affairs Management, Unternehmensberatung

7/2012 – 12/2013

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

Pharmazie, Business Development, Change Management, Compliance management, Interkulturelle Kommunikation, Lizenzmanagement, Product-lifecycle-management (PLM), Produktmanagement, Prozess- / Workflow, Qualitätsmanagement (allg.), Regulatory Affairs Management, Schulung / Coaching (allg.)

3/2009 – 7/2012

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)

Change Management, Compliance management, HTML, Kommunikation (allg.), Lizenzmanagement, Pharmazie, Product-lifecycle-management (PLM), Projektdurchführung, Projektmanagement, Prozess- / Workflow, Recht (allg.), Regulatory Affairs Management, Wissensmanagement

10/2008 – 12/2008

- 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

Gesundheit (allg.), Klinische Studie, Medizin, Pharmazie, Projektdurchführung, Projektmanagement

4/2002 – 12/2004

- Employer Services

Arbeitsrecht, Arbeitslosenversicherung, Arbeitsvermittlung, Finanzen (allg.), Kommunikation (allg.), Mergers / Acquisitions, Personalwesen (allg.), Prozess- / Workflow, Schulung / Coaching (allg.)

2/2000 – 6/2001

- 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

Angewandte Forschung, Biologie, Forschung & Entwicklung (allg.), Grundlagenforschung, Medizinforschung, Naturwissenschaft