a Randstad company

Regulatory Affairs EU, USA, EM

Profil
Top-Skills
Regulatory Affairs Consulting Regulatory Affairs Management
Verfügbar ab
12.09.2022
Aktuell verfügbar - Der Experte steht für neue Projektangebote zur Verfügung.
Verfügbar zu
100%
davon vor Ort
100%
Einsatzorte

PLZ-Gebiete
Länder
Ganz Deutschland
Remote-Arbeit
möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

15 Jahre 6 Monate

2007-04

heute

Strategic advice

Independent Consultant
Rolle
Independent Consultant
Projektinhalte

Strategic advice to international companies in pharmaceutical, biotechnology and medical device industries with emphasis on clinical development, marketing authorization of small molecule drugs and biologics/ATMPs, life cycle management, regulatory filing and guidance on clinical and scientific issues. Development and implementation of regulatory strategies and support for all phases of international drug development, out-licensing, client representation to the EMA, the FDA, and national competent authorities within the European Union and Emerging Markets, risk management, and postmarketing surveillance. Identification of risks, assessment of regulatory impact on clinical and CMC issues, Scientific Advice, and coordination of regulatory filings including MAAs, BLAs, PIPs, CTAs, INDs, variations, renewals, PSURs, and ad hoc dossiers. 

  • Provided strategic advice to Johnson & Johnson, Takeda Global Research & Development, Sanofi, Biogen, Abbott Laboratories, GlaxoSmithKline, Merz Pharmaceuticals, Otsuka, and CSOs
  • Provided customized regulatory services in coordination of multiple projects
  • Prepared and reviewed submission dossiers for the USA and the European Union
  • Facilitated regulatory submissions from early development stages to approval 
  • Provided drug development support for European and American markets, Switzerland, CIS countries, Middle East, Pacific Rim, South Africa, and Australia
  • Managed compliance projects and remediation plans 
  • Communicated and successfully negotiated with client matrix teams and competent regulatory authorities as part of the process

2005-2007: Worldwide Regulatory Strategies


Role: Consultant

Customer: Pfizer Ltd., Medical Department/Regulatory Affairs, Pfizer Global Pharmaceuticals, and Pfizer Global Research and Development, Walton Oaks, Surrey, United Kingdom


Tasks:

Regulatory submissions and license maintenance; UK and Irish documentation, planning, design and submission of variations and renewals to European regulatory authorities; clinical submissions/core data sheet updates, changes to SmPC, package leaflet and label, and CMC variations; submission of CTAs, MAAs, PIPs, PSURs, and ad hoc responses to internal and external queries; progress monitoring, preparation of reports, interface and communication with matrix team and regulatory authorities (MHRA, HPRA/IMB, EMA); and GXP compliance measures.

  • Managed over 50 licenses
  • Turned around delicate projects
  • Provided quality advice upon complex medical and scientific queries
  • Guided executive-level personnel


2001-2005: Clinical project management


Role: Consultant/Scientific Advisor and Manager of Regulatory Affairs

Customer: Abbott Laboratories, Inc., Focus Technologies Inc., Genset Corporation, and Committee for World Health, San Diego/Los Angeles, California; Chicago, Illinois; USA/Germany


Tasks:

Clinical project management in compliance with ICH-GCP; protocol design, medical writing and documentation in clinical study support phase I to IV; regulatory strategy support, and preparation and submission of major dossiers (INDs, NDAs, BLAs, CTAs, MAAs); identification of licensing opportunities, preparation of project plans, reports, and presentations; time management in interface with matrix teams and regulatory authorities (FDA, EMA).

  • Supported NDA submissions (USA) and MAAs (Europe)
  • Prepared early-to-late phase regulatory documents
  • Evaluated clinical datasets safety and long-term efficacy
  • Managed US- and European projects for product licensing


1999-2001: Structure-based drug design and preclinical development


Role: Research Scientist

Customer: Agouron Pharmaceuticals/Pfizer Inc., Department of Crystallography, Neurodegenerative Disease Research Division; San Diego, California


Tasks:

Structure-based drug design and preclinical development: protein genetic engineering, overexpression, analysis, and purification (FPLC, ion exchange chromatography, size exclusion- and affinity chromatography). Protein-ligand crystallization and characterization at the tertiary structure level by X-ray crystallography. Collaboration with cross-functional project teams for drug validation (Parke-Davis and Harvard Medical School) including in vitro and in vivo toxicity and pharmacology studies, risk assessments, and risk/benefit profile development.

  • Obtained diffraction-quality crystals of a novel compound-target protein complex in a ligand-dependent crystallization process; structure solved
  • Solved structure of a prospective prelead compound complexed with in vivo target protein
  • Overexpressed and engineered new inhibitor proteins for a key target; analyzed and purified inhibitor/target protein complexes for X-ray crystallography
  • Periodic progress reports and presentations


1997-1999: Gene therapy project


Role: Research Scientist

Customer: University of California San Diego, Center for Molecular Genetics, Department of Pediatrics, Department of Ophthalmology; San Diego, California


Tasks:

Gene therapy project: in vitro and in vivo development of packaging cell lines for improvement of retroviral vector systems; formulations development and efficacy testing for manufacturing and clinical studies (Joint venture UCSD/Boehringer Mannheim/Roche). Endocrinology: development and improvement of therapeutics based on prostaglandin-mediated signal transduction and effects on extracellular matrix turnover (Pharmacia & Upjohn/Pfizer Inc.)

  • Selected and screened new cell lines for in vivo delivery of therapeutic genes with emphasis on high titer, reduced immunogenicity and tissue-specific targeting
  • Developed formulations for clinical and commercial applications
  • Investigated molecular and cellular processes and receptor physiology in vitro and in vivo for the identification of novel therapeutic targets
  • Documentation, manuscript- and grant writing


1996-1997: Oncology/Gene therapy program


Role: Research Fellow

Customer: Tulane University School of Medicine, Department of Pathology and Laboratory Medicine, Department of Dermatology; New Orleans, Louisiana


Tasks:

Oncology/Gene therapy program in support of clinical trials for breast carcinoma and prostate cancer including structure-activity studies of tumor suppressor protein p53.

  • Characterized wild type-/mutant p53 complexes at molecular and structural levels (CD/ NMR spectroscopy/X-ray crystallography) in context with cell cycle regulation and oncogenesis
  • Designed research projects, developed internal and external collaborations ? Evaluated scientific quality of data in support of ongoing clinical trials
  • Study reports, protocols, presentations, and grant submissions
  • Interface with clinicians and research personnel
  • Trained M.D.-resident on molecular methods including analysis by PCR of HTLV I and HTLV II in leukemia patients


1994-1996: Oncology/Gene therapy program


Role: Research Associate

Customer: Markey Cancer Center, Department of Microbiology and Immunology / University of Kentucky; Lexington, Kentucky


Tasks:

Oncology/Gene therapy program: development of immunoconjugates as vector systems for preclinical studies and clinical trials; implementation and validation of antibody-mediated cell-specific gene delivery in vitro and in vivo using B-cell lymphoma models.

  • Designed, synthesized and characterized new antibody-conjugates for therapeutic gene transfer applications; published results
  • Produced antibodies in hybridoma cells and mouse ascites; synthesized and purified immunoconjugates, analyzed cell binding and -internalization of immunoconjugates by FACS, immunofluorescence microscopy, and radiolabeled conjugates
  • Developed ELISA- and cellular ELISA assays; transfected cultured cells by antibody-polycation/DNA
  • complexes, analyzed reporter gene expression, and demonstrated efficacy compared to liposome-mediated transfections
  • Evaluated in vivo pharmacology of immunoconjugates in murine models and analyzed gene expression in vivo by cryosection/immunohistochemistry, and RT-PCR
  • Developed and validated formulations for large-scale production
  • Analyzed effect of angiogenesis inhibitors on the regulation of growth factor- and hormone receptor expression in endothelial cells; monitored expression of tumor- suppressor proteins and oncogenes for the validation of new angiostatic compounds
  • Trained laboratory personnel at Ph.D.-, M.S.- and B.S.- levels on gene- and cell technology and in vivo studies
  • Interface and communication with clinicians and external resources
  • Study reports, protocols, scientific manuscripts, and grant submissions


1992-1993: Endocrinology: steroid- and retinoid-mediated gene regulation


Role: Postdoctoral Scholar

Customer: University of Kentucky, Graduate Center for Toxicology / Molecular & Cell Biology Group; Lexington, Kentucky


Tasks:

Endocrinology: steroid- and retinoid-mediated gene regulation in Trichoplusia ni and Drosophila with emphasis on the identification and characterization of new target receptors. Structure-activity studies on endoparasite proteins.

  • Characterized enhancer- and silencer regions in several key promoters of developmentally regulated genes; published results
  • Analyzed promoter function by PCR-mediated subcloning of different regions in eight genes and transient reporter gene expression in various cell lines
  • Screened genomic- and cDNA libraries, isolated and characterized a new heat shock-protein 90 analogue for functional studies
  • Characterized protein related to endoparasite function including in-frame subcloning, overexpression, analysis (Western blot, SDS-PAGE/staining, isoelectric focusing), and purification by affinity chromatography and chromatofocusing for X-ray crystallography
  • Characterized new genes and endoparasite polydnavirus sequences
  • Completed open projects involving experimental procedures and computer-aided analyses
  • Trained laboratory personnel at Ph.D.- and graduate student levels
  • Two NIH grants and one NSF grant approved

1986-1991

Max-Planck-Institut für Züchtungsforschung Cologne, Germany

Ph.D.-Student, Scientist


Key Aspects:

Research in plant molecular genetics: construction of a high-density genetic linkage map in Solanum tuberosum, mapping and profiling of disease resistance traits, and validation of new markers for genetic fingerprinting.

  • Grant provided by the Federal Department of Science and Technology
  • Constructed a random genomic library for RFLP mapping (restriction fragment length polymorphism)
  • Used Southern blot analysis to screen crop varieties; constructed a RFLP linkage map by computer-aided segregation analysis
  • Mapped nematode resistance genes in collaborative efforts
  • Identified and characterized new highly variable sequences for genotyping
  • Ph.D.-thesis: on request
  • Provided basis for expanding project in international collaboration
  • Increased funding by the Federal Department of Science and Technology


1986

M.S. Biology/Chemistry, University of Hannover, Germany


Key Aspects:

Both graduate and undergraduate studies focused on Molecular Biology, Genetics, Biochemistry, Microbiology, Parasitology, Organic and Inorganic Chemistry

English
German
Latin

Top Skills
Regulatory Affairs Consulting Regulatory Affairs Management
Produkte / Standards / Erfahrungen / Methoden

REGULATORY AFFAIRS & RISK MANAGEMENT

Over fifteen years experience in all phases of clinical research and development, most recently focusing on Regulatory Affairs Consulting at Pharmaceutical Research Associates (PRA). Extensive knowledge base gained from product development efforts in advanced research and regulatory affairs consulting for Takeda, Johnson & Johnson, Pfizer, GlaxoSmithKline, Sanofi, Biogen, Abbott Laboratories, University of California San Diego Medical Center, Tulane University School of Medicine, Markey Cancer Center, Center for Toxicology, and Max-Planck-Institute in areas that include:

  • Development of regulatory strategies for the US and Europe, preparation of CTD dossiers, application for marketing authorization of new chemical entities and biologics in Europe and Asia (MRP, CP, national); advanced therapy medicinal products (ATMPs), pediatric investigation plans (PIPs), joint product licensing and registration across US-American and European markets, liaising with US-, European and Asian teams, and interface and communication with regulatory authorities (FDA, EMA/CHMP/CAT).


Other areas of involvement have included:

  • Regulatory consulting, licensing, and license maintenance; planning, design and submission of variations and renewals to European competent authorities; clinical submissions/core data sheet updates, PSURs, SmPC, PIL updates, and CMC variations; submission of CTAs and MAAs; queries, reports, interface and communication with matrix team and regulatory authorities (MHRA, BfArM/PEI, EMA), GXP compliance measures.
  • Early-to-late phase clinical study oversight, data evaluation and documentation; development of regulatory strategies, interface and communication with FDA and EMA; Scientific Advice, liaising with US-American and European corporate matrix teams, and regulatory submissions (CTAs, INDs, MAAs, BLAs, NDAs), and license maintenance (variations, renewals).
  • New Drug Applications (NDAs) for marketing authorization in the US; Early-to late stage clinical study oversight and regulatory affairs support; preparation of dossier (Preclinical and Clinical Modules), writing of Clinical Study Reports and related documents, RMPs, RiskMAPs, Safety updates, ad hoc reports upon FDA request, review and interpretation of clinical data and relevant scientific literature, interface with matrix team and FDA, writing of presentations for team meetings, and participation in NDA filing; supervision of clinical study activities. 
  • Evaluation of clinical datasets including toxicology and pharmacology/PKDM reports and statistical analysis plans; clinical data interpretation including exposure, dose and response to therapeutics; safety evaluation including toxicity and adverse events; long-term efficacy evaluation, participation of NDA preparation and filing; PSURs, cumulative safety reports, ad hoc reports, presentations for external meetings and cross-functional teams.
  • Medical writing and Intellectual Property management: writing and preparation of documents for regulatory submissions: DSURs, Clinical Study Reports, Investigator Brochures, INDs, BLAs, and NDAs; Pharmacovigilance including PSURs, RMPs, and ad hoc reports; evaluation of new procedural methodologies and clinical relevance of corresponding products in light of published literature and competitive challenges, submission of patent applications.


Objectives

Drug Development & Commercialization, Regulatory Affairs, Risk Management

  • Clinical Development, Regulatory Affairs Consulting, and Risk Management
  • FDA/CDER/CBER and EMA/CHMP/CAT Interface and Communication
  • Regulatory Submissions/EU: CP, MRP, National MAAs, PIPs; Variations, Renewals
  • Clinical Study Reports, PSURs, RMPs; INDs, BLAs, and NDAs
  • Clinical Documentation, Drug Effectiveness Evaluation and Risk Management
  • Oncology, Anti-Infectives, Cardiovascular-, CNS-, and Metabolic Diseases 


ADDITIONAL SKILLS

Fully computer literate in platforms and applications that include MS Office/DOS/Windows; PC, Macintosh ? Microsoft Word, PowerPoint, Excel, Internet Explorer, Outlook; sequence analysis using GCG/WISGEN, PC-Gene, BLAST, and SEQUANAL; Graphics using Sigmaplot and Cricket Graph; and statistics.

MEMBERSHIPS, PUBLICATIONS, PRESENTATIONS: on request

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