freiberufler Drug Regulatory Affairs + Medical Affairs Consultant auf freelance.de

Drug Regulatory Affairs + Medical Affairs Consultant

zuletzt online vor wenigen Tagen
  • auf Anfrage
  • Nordrhein-Westfalen
  • Weltweit
  • de  |  en
  • 16.11.2022

Kurzvorstellung

14 y Drug Regulatory Affairs
8 y CMC
1 y Medical Affairs
RA: Strategy, Maintenance, LCM, New Applications/Line Ext., Labeling
PV: Signal Management, ARISg
Countries: EU, CIS, CEFTA, APAC, MEA, LATAM, USA, CAN
full-time + part-time, on site + remote

Ich biete

  • Change-Request-Management
  • Compliance management
  • Gute Herstellungspraxis (GMP)
  • Interim Management
  • Lizenzmanagement
  • Regulatory Affairs Management
  • Technische Dokumentation
  • Unternehmensberatung

Projekt‐ & Berufserfahrung

freiberuflicher Regulatory Affairs Consultant
Kundenname anonymisiert, Nürnberg
12/2021 – offen (1 Jahr)
Pharmahersteller
Tätigkeitszeitraum

12/2021 – offen

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, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung

freiberuflicher Regulatory Affairs Consultant
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

Regulatory Affairs Management

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

4/2021 – 3/2022

Tätigkeitsbeschreibung

- 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)

Eingesetzte Qualifikationen

Regulatory Affairs Management

freiberuflicher Regulatory Affairs Consultant
Kundenname anonymisiert, Wien
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

Regulatory Affairs Management

freiberuflicher Regulatory Affairs+Medical Affairs Consultant
Kundenname anonymisiert, Sulzbach
10/2019 – 6/2021 (1 Jahr, 9 Monate)
Pharmahersteller
Tätigkeitszeitraum

10/2019 – 6/2021

Tätigkeitsbeschreibung

Regulatory Affairs Consultant for Germen Marketing Authorizations
Medical Affairs Consultant
Deputy RPPV (Stufenplanbeauftragter)

Eingesetzte Qualifikationen

Regulatory Affairs Management

freiberuflicher Regulatory Affairs Consultant
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
Maintenance (variations + renewals)
New Registrations + Line Extensions
Temporary Authorizations

Eingesetzte Qualifikationen

Regulatory Affairs Management

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
Variations

Eingesetzte Qualifikationen

Regulatory Affairs Management

freiberuflicher CMC Specialist / Regulatory Affairs Consultant
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

Compliance management, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung

freiberuflicher CMC-Specialist/Regulatory Affairs Consultant
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

Compliance management, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung

CMC-Compliance Manager
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, Interim Management, Regulatory Affairs Management, Technische Dokumentation, Unternehmensberatung

freiberuflicher Regulatory Compliance Manager
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

Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Regulatory Affairs Management, Unternehmensberatung

freiberuflicher 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

Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Regulatory Affairs Management, 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

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

Scientific Employee, Drug Licensing (Procedural Management) (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, HTML, Kommunikation (allg.), Lizenzmanagement, Projektmanagement, Recht (allg.), Regulatory Affairs Management, Wissensmanagement

Scientific Employee (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

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

Finanzen (allg.), Kommunikation (allg.), Mergers / Acquisitions, Personalwesen (allg.), 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 (allg.), Grundlagenforschung, Medizinforschung, Naturwissenschaft

Zertifikate

Betäubungsmittel Verantwortlicher
Mai 2019
CMC Specialist
Januar 2015
Legal expertise in the retail trade with OTC drugs in line with §50 AMG (German Drug Law)
November 2014
Quality- and Manufacturing Know-How for Regulatory Affairs/CMC
Juli 2014

Ausbildung

Biologie

(Diplom)
Jahr: 1999
Ort: Köln

Qualifikationen

Regulatory Affairs Consulting worldwide
Regulatory Affairs Management worldwide
GAP-Analysis / Regulatory Compliance
CMC (Chemistry, Manufacturing and Controls) = Quality-Dossier Management
Labeling
Product Life Cycle Management
Licensing Requirements
Communication

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.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
4300
Berufserfahrung
22 Jahre und 9 Monate (seit 02/2000)

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden