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Submitted URL: http://pharmalex.com.au/
Effective URL: https://www.pharmalex.com/country/australia/
Submission: On March 25 via api from US — Scanned from AU
Effective URL: https://www.pharmalex.com/country/australia/
Submission: On March 25 via api from US — Scanned from AU
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https://www.pharmalex.com/
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Skip to content * * 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 * * FDA clarifies use of Clinical Data in Premarket Notification Submissions Blog & Article * 22nd March 2024 What is the right validation model? Journal Article * 21st March 2024 Exploring the interactions between validation and technology transfer Podcast * 7th February 2024 We are now Cencora PharmaLex Company News * 30th January 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 * * FDA clarifies use of Clinical Data in Premarket Notification Submissions Blog & Article * 22nd March 2024 What is the right validation model? Journal Article * 21st March 2024 Exploring the interactions between validation and technology transfer Podcast * 7th February 2024 We are now Cencora PharmaLex Company News * 30th January 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 * Contact Us * Imprint * Data Protection * Terms and Conditions 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 NEWSLETTER SIGN UP SIGN UP NOW ©2024 PHARMALEX GMBH. ALL RIGHTS RESERVED. Linkedin-in Youtube START TYPING AND PRESS ENTER TO SEARCH Search... 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