Drug Regulatory Affairs + Medical Affairs Consultant
- Verfügbarkeit einsehen
- 0 Referenzen
- auf Anfrage
- Nordrhein-Westfalen
- Weltweit
- de | en
- 14.12.2022
Kurzvorstellung
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
Qualifikationen
Projekt‐ & Berufserfahrung
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)
Change-Request-Management, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung
11/2021 – 11/2021
Tätigkeitsbeschreibung
- Preparation of regulatory expert reports on the business development/diligence process
- Dossier audit
Regulatory Affairs Management
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)
Regulatory Affairs Management
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
Regulatory Affairs Management
10/2019 – 6/2021
Tätigkeitsbeschreibung
Regulatory Affairs Consultant for Germen Marketing Authorizations
Medical Affairs Consultant
Deputy RPPV (Stufenplanbeauftragter)
Regulatory Affairs Management
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
Regulatory Affairs Management
11/2017 – 2/2018
Tätigkeitsbeschreibung
Regulatory Affairs Management of Generic Products of 35 Active Substances
Variations
Regulatory Affairs Management
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
Compliance management, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung
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
Compliance management, Interim Management, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung
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
Compliance management, Interim Management, Regulatory Affairs Management, Technische Dokumentation, Unternehmensberatung
8/2015 – 10/2015
Tätigkeitsbeschreibung
Product Groups: Thyrostatic substance (Rx)
Tasks:
CMC-Life-Cycle-Management
Preparation for Tech-Transfers
GAP-Analysis
Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Regulatory Affairs Management, Unternehmensberatung
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
Change Management, Compliance management, Interim Management, Interkulturelle Kommunikation, Lizenzmanagement, Regulatory Affairs Management, Unternehmensberatung
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
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
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)
Change Management, HTML, Kommunikation (allg.), Lizenzmanagement, Projektmanagement, Recht (allg.), Regulatory Affairs Management, Wissensmanagement
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
Gesundheit (allg.), Klinische Studie, Medizin, Pharmazie, Projektmanagement
4/2002 – 12/2004
Tätigkeitsbeschreibung- Employer Services
Eingesetzte QualifikationenFinanzen (allg.), Kommunikation (allg.), Mergers / Acquisitions, Personalwesen (allg.), Schulung / Coaching (allg.)
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
Angewandte Forschung, Biologie, Forschung & Entwicklung (allg.), Grundlagenforschung, Medizinforschung, Naturwissenschaft
Zertifikate
Ausbildung
Köln
Über mich
Excellent team working and cross-cultural communication skills. Pragmatic and creative problem solving capabilities.
Weitere Kenntnisse
Regulatory Affairs Management worldwide
GAP-Analysis / Regulatory Compliance
CMC (Chemistry, Manufacturing and Controls) = Quality-Dossier Management
Labeling
Product Life Cycle Management
Licensing Requirements
Communication
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
Kontaktdaten
Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.
Jetzt Mitglied werden