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Text Content

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 * 
 * About Us
   * * * About UsWe are leading provider of specialized services for the
         pharmaceutical, biotech and medical device industries, compliance is
         our priority.
       * SustainabilityWe are focusing our efforts on initiatives that revolve
         around education, empowerment and inclusivity and sustainability.
     * * Management TeamOur management team is committed to create a friendly
         working environment, provide confidence to our customers and support a
         environmental-friendly company.
       * Our LocationsWe service our clients through our regional hubs that
         collaborate on projects at global, regional and local levels
     * * Corporate Social ResponsibilityHaving the ability to invest in
         sustainable environmental and social wellbeing is an important part of
         our attitude to business as well as helping to reinforce our values.
       * TrainingEnhancing our industry by delivering high-quality specialist
         training courses.
 * Solutions
   
   * * * Industry Solutions
         
          * Strategic and Scientific Consultancy
          * Integrated Product Development
          * Innovations to Market
          * Post-launch Outsourcing
          * Local Affiliate Services
          * Business and Portfolio Mergers & Acquisitions
         
          * Strategic and Scientific Consultancy
          * Integrated Product Development
          * Innovations to Market
          * Post-launch Outsourcing
          * Local Affiliate Services
          * Business and Portfolio Mergers & Acquisitions
         
         Industry Sectors
         
          * Biotech
          * Pharmaceutical & Consumer Health
          * MedTech
         
          * Biotech
          * Pharmaceutical & Consumer Health
          * MedTech
         
         Departments
         
         Services
         
         Research and Development
         Statistics and Data Science
         Market Access
         Patient Safety (Pharmacovigilance)
         Regulatory Affairs and CMC
         Quality Management and Compliance
         Training
         Research and Development
          * Clinical Development Services
          * Clinical Trial Applications
          * Development Strategy
          * Toxicological Services and Risk Assessment
         
         Statistics and Data Science
          * Clinical Biostatistics
          * CMC Statistics
          * Discovery Statistics
          * Omics Data Science
         
         Market Access
          * Health economics and outcomes research (HEOR)
          * Market Access Strategy
          * Pricing and Reimbursement
         
         Patient Safety (Pharmacovigilance)
          * Clinical Trials Adverse Event Processing
          * Gap Analysis and Consulting
          * ICSR Management
          * Literature Surveillance
          * Monitoring and Signal Detection
          * Pharmacovigilance Audits
          * Qualified Person for Pharmacovigilance (QPPV)
         
         Regulatory Affairs and CMC
          * Agency Interactions
          * CMC Biologics
          * CMC Services
          * eCTD, System Operations and Data Management
          * Post-Approval Maintenance
          * Promotional Materials & Compliance
          * Regulatory Writing / Scientific and Technical Writing
         
         Quality Management and Compliance
          * Commissioning, Qualification and Validation
          * Computer System Validation (CSV)
          * GxP Audit
          * GxP Technical Consulting
          * Quality Systems and Compliance
         
         Enhancing our industry by delivering high-quality specialist training
         courses.
 * Solutions
   * Industry Solutions
     * Strategic and Scientific Consultancy
     * Integrated Product Development
     * Innovations to Market
     * Post-launch Outsourcing
     * Local Affiliate Services
     * Business and Portfolio Mergers & Acquisitions
   * Sectors
     * Biotech
     * Pharmaceutical & Consumer Health
     * MedTech
   * Departments
     * Research and Development
     * Statistics and Data Science
     * Market Access
     * Patient Safety (Pharmacovigilance)
     * Regulatory Affairs and CMC
     * Quality Management and Compliance
 * Insights
   * * * News & Events
         * Webinars
         * Events
         * Company News
     * * Thought Leadership
         * White Papers
         * Infographics
         * Blog & Articles
         * Videos
         * Journal Articles
         * Podcasts
     
     * * Tackling challenges with nitrosamine risk assessment
         
         Blog & Article
          * 16th April 2024
         
         Centralize, Modernize, Harmonize: The Acceleration of Regulatory
         Digital Trends
         
         Journal Article
          * 27th March 2024
         
         Clinical trials regulation (CTR)
         
         Infographic
         
         Exploring the interactions between validation and technology transfer
         
         Podcast
          * 7th February 2024
 * Insights
   * News & Events
     * Webinars
     * Events
     * Company News
   * Thought Leadership
     * White Papers
     * Infographics
     * Blog & Articles
     * Videos
     * Journal Articles
     * Podcasts
 * Digital Innovation
 * Careers
   * * * CareersWe are dedicated to creating a sustainable work-life balance to
         support our highly motivated team in this fun and challenging
         environment.
       * Your Application ProcessWe want to give you some tips for the
         application process.
     * * Life at PharmaLexWe are proud of what our employees say about us. Read
         their testimonials.
     * * Current OpportunitiesWe prefer online applications – it’s very easy and
         is the fastest way to success for you and us. You can easily upload
         your attachments, such as your CV and cover letter, in all common
         formats.
 * Contact Us
 * 
 * Global Reach
 * 

 * 
 * About Us
   * * * About UsWe are leading provider of specialized services for the
         pharmaceutical, biotech and medical device industries, compliance is
         our priority.
       * SustainabilityWe are focusing our efforts on initiatives that revolve
         around education, empowerment and inclusivity and sustainability.
     * * Management TeamOur management team is committed to create a friendly
         working environment, provide confidence to our customers and support a
         environmental-friendly company.
       * Our LocationsWe service our clients through our regional hubs that
         collaborate on projects at global, regional and local levels
     * * Corporate Social ResponsibilityHaving the ability to invest in
         sustainable environmental and social wellbeing is an important part of
         our attitude to business as well as helping to reinforce our values.
       * TrainingEnhancing our industry by delivering high-quality specialist
         training courses.
 * Solutions
   
   * * * Industry Solutions
         
          * Strategic and Scientific Consultancy
          * Integrated Product Development
          * Innovations to Market
          * Post-launch Outsourcing
          * Local Affiliate Services
          * Business and Portfolio Mergers & Acquisitions
         
          * Strategic and Scientific Consultancy
          * Integrated Product Development
          * Innovations to Market
          * Post-launch Outsourcing
          * Local Affiliate Services
          * Business and Portfolio Mergers & Acquisitions
         
         Industry Sectors
         
          * Biotech
          * Pharmaceutical & Consumer Health
          * MedTech
         
          * Biotech
          * Pharmaceutical & Consumer Health
          * MedTech
         
         Departments
         
         Services
         
         Research and Development
         Statistics and Data Science
         Market Access
         Patient Safety (Pharmacovigilance)
         Regulatory Affairs and CMC
         Quality Management and Compliance
         Training
         Research and Development
          * Clinical Development Services
          * Clinical Trial Applications
          * Development Strategy
          * Toxicological Services and Risk Assessment
         
         Statistics and Data Science
          * Clinical Biostatistics
          * CMC Statistics
          * Discovery Statistics
          * Omics Data Science
         
         Market Access
          * Health economics and outcomes research (HEOR)
          * Market Access Strategy
          * Pricing and Reimbursement
         
         Patient Safety (Pharmacovigilance)
          * Clinical Trials Adverse Event Processing
          * Gap Analysis and Consulting
          * ICSR Management
          * Literature Surveillance
          * Monitoring and Signal Detection
          * Pharmacovigilance Audits
          * Qualified Person for Pharmacovigilance (QPPV)
         
         Regulatory Affairs and CMC
          * Agency Interactions
          * CMC Biologics
          * CMC Services
          * eCTD, System Operations and Data Management
          * Post-Approval Maintenance
          * Promotional Materials & Compliance
          * Regulatory Writing / Scientific and Technical Writing
         
         Quality Management and Compliance
          * Commissioning, Qualification and Validation
          * Computer System Validation (CSV)
          * GxP Audit
          * GxP Technical Consulting
          * Quality Systems and Compliance
         
         Enhancing our industry by delivering high-quality specialist training
         courses.
 * Solutions
   * Industry Solutions
     * Strategic and Scientific Consultancy
     * Integrated Product Development
     * Innovations to Market
     * Post-launch Outsourcing
     * Local Affiliate Services
     * Business and Portfolio Mergers & Acquisitions
   * Sectors
     * Biotech
     * Pharmaceutical & Consumer Health
     * MedTech
   * Departments
     * Research and Development
     * Statistics and Data Science
     * Market Access
     * Patient Safety (Pharmacovigilance)
     * Regulatory Affairs and CMC
     * Quality Management and Compliance
 * Insights
   * * * News & Events
         * Webinars
         * Events
         * Company News
     * * Thought Leadership
         * White Papers
         * Infographics
         * Blog & Articles
         * Videos
         * Journal Articles
         * Podcasts
     
     * * Tackling challenges with nitrosamine risk assessment
         
         Blog & Article
          * 16th April 2024
         
         Centralize, Modernize, Harmonize: The Acceleration of Regulatory
         Digital Trends
         
         Journal Article
          * 27th March 2024
         
         Clinical trials regulation (CTR)
         
         Infographic
         
         Exploring the interactions between validation and technology transfer
         
         Podcast
          * 7th February 2024
 * Insights
   * News & Events
     * Webinars
     * Events
     * Company News
   * Thought Leadership
     * White Papers
     * Infographics
     * Blog & Articles
     * Videos
     * Journal Articles
     * Podcasts
 * Digital Innovation
 * Careers
   * * * CareersWe are dedicated to creating a sustainable work-life balance to
         support our highly motivated team in this fun and challenging
         environment.
       * Your Application ProcessWe want to give you some tips for the
         application process.
     * * Life at PharmaLexWe are proud of what our employees say about us. Read
         their testimonials.
     * * Current OpportunitiesWe prefer online applications – it’s very easy and
         is the fastest way to success for you and us. You can easily upload
         your attachments, such as your CV and cover letter, in all common
         formats.
 * Contact Us
 * 
 * Global Reach
 * 

Asia-Pacific


AUSTRALIA

Contact PharmaLex Australia


LOCAL CONTACT

Grant Bennett
Managing Director


PharmaLex Australia
Suite 4, Level 10, 1 Chandos Street, St Leonards NSW 2065, Australia
 * +61 2 9906 2984

Download Local Terms & Conditions

Download information collection statement – Pharmacovigilance and Patient
Inquiries

Download Privacy Policy

Contact Us



LATEST NEWS, ARTICLES AND EVENTS FOR AUSTRALIA

Blog & Article


PROGRESS ON THE NEW ZEALAND THERAPEUTIC PRODUCTS BILL

 * 23rd June 2023

Blog & Article


TGA’S UPDATES AND KEY CHANGES IN THE MDR TRANSITION STRATEGY

 * 22nd May 2023

Event


2023 ARCS ANNUAL CONFERENCE

 * June 6th, 2023

Blog & Article


HONG KONG PAVES THE WAY FOR MANDATORY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

 * 13th February 2024

Blog & Article


REGULATION OF COMPANION DIAGNOSTICS IN AUSTRALIA

 * 17th January 2024

Blog & Article


AMID GLOBAL REGULATORY COMPLEXITY, AUSTRALIA SHINES A LIGHT ON CONVERGENCE AND
COLLABORATION

 * 12th December 2023

Blog & Article


PREPARING FOR DEVICE TRACKING: NEXT STEPS WITH AUSTRALIA’S UDI

 * 16th November 2023

Webinar


INTERNATIONAL REGULATORY CONVERGENCE FOR MEDICAL DEVICES AND IN-VITRO
DIAGNOSTICS

 * October 12th, 2023

Blog & Article


ARCS TAKEAWAYS: IVDR IN AN AUSTRALIAN CONTEXT

 * 17th July 2023

Blog & Article


TGA UPDATES ITS RECLASSIFICATION TIMELINES

 * 11th July 2023

Blog & Article


AUSTRALIAN REGULATORS ARE REMOVING THE REQUIREMENT FOR PACKAGING OF INJECTABLE
MEDICINES TO INCLUDE HARD COPIES OF PRODUCT INFORMATION

 * 10th July 2023

Blog & Article


REGULATION OF PERSONALIZED MEDICAL DEVICES IN AUSTRALIA

 * 4th July 2023

Blog & Article


PROGRESS ON THE NEW ZEALAND THERAPEUTIC PRODUCTS BILL

 * 23rd June 2023

Blog & Article


TGA’S UPDATES AND KEY CHANGES IN THE MDR TRANSITION STRATEGY

 * 22nd May 2023

Event


2023 ARCS ANNUAL CONFERENCE

 * June 6th, 2023

Blog & Article


HONG KONG PAVES THE WAY FOR MANDATORY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

 * 13th February 2024

Blog & Article


REGULATION OF COMPANION DIAGNOSTICS IN AUSTRALIA

 * 17th January 2024

Blog & Article


AMID GLOBAL REGULATORY COMPLEXITY, AUSTRALIA SHINES A LIGHT ON CONVERGENCE AND
COLLABORATION

 * 12th December 2023


Previous
Next




KEY MEMBERS OF OUR TEAM


ROBERT STRINGER

Senior Director, Operations

Robert has more than 25 years’ experience in the Australian and New Zealand
pharmaceutical industry. Robert’s career extends to managing multi-national
corporate teams in Regulatory Affairs, Quality Assurance, Product Development,
Clinical Research and Strategic Planning & Business Development. Roberts career
highlights include achieving the world-first regulated market approval of a
biosimilar.

Linkedin-in


LOIS REES

Finance Director



JENNIE BRANDENBURG

Senior Manager, Human Resources



ELISE BROWN

Executive Assistant




JOSIE GABITES

Director, Head of PV & Medical Services, Australia



JEAN BOUDAUD

Director, Head of Medical Devices / IVD Australia

Jean has proven experience in all phases of the product lifecycle, driving
compliance from concept initiation through to commercialisation and post-market
support. He provides Regulatory and Quality Assurance expertise to a broad range
of companies and supports projects involving various medical technologies. He is
bilingual in French and English and holds a Masters’ Degree of Engineering.

Linkedin-in


PIETY ROCHA

Director, Head of Regulatory Affairs Team Australia

Piety has worked in the Australian and New Zealand Pharmaceutical Industry for
over 20 years. Piety is a skilled Regulatory Affairs professional, and an
experienced people manager having managed Regulatory affairs teams both locally
and internationally within large pharmaceutical companies.

Linkedin-in


DAINA VANAGS

Senior Director, Principal Consultant Biopharma-Excellence,
Head of Development Consulting Services (Australia)

Daina has 16 years’ experience in pharmaceutical product development (proteins,
antibodies, biosimilars, vaccines, cell-based products), including biotechnology
executive experience (Australia, USA). Daina trained in pharmacology with a
first-class honours and PhD (University of Adelaide), post-doctoral positions in
clinical pharmacology (Oxford University, UK) and toxicology (Karolinska
Institute, SE).

Linkedin-in


YVETTE ELVY

Senior Marketing Manager, APAC & Global MedTech



MOHAMMAD ASAD

Regional Sales Manager, Asia Pacific




COMPANY

 * About Us
 * Corporate Social Responsibility
 * Sustainability
 * Management Team
 * Sectors

 * About Us
 * Corporate Social Responsibility
 * Sustainability
 * Management Team
 * Sectors


USEFUL LINKS

 * Contact Us
 * Imprint
 * Data Protection
 * Terms and Conditions
 * UK Modern Slavery Act Statement

 * Contact Us
 * Imprint
 * Data Protection
 * Terms and Conditions
 * UK Modern Slavery Act Statement


SOLUTIONS

 * Strategic and Scientific Consultancy
 * Integrated Product Development
 * Innovations to Market
 * Post-launch Outsourcing
 * Local Affiliate Services
 * Business and Portfolio Mergers & Acquisitions

 * Strategic and Scientific Consultancy
 * Integrated Product Development
 * Innovations to Market
 * Post-launch Outsourcing
 * Local Affiliate Services
 * Business and Portfolio Mergers & Acquisitions


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©2024 PHARMALEX GMBH. ALL RIGHTS RESERVED.
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