Regulatory Affairs Specialist CMC
2 weeks ago
{"h2": "About the Role", "p": "We're seeking a highly skilled Principal Associate, Regulatory Affairs CMC to provide strategic advice and support to our Project/Product teams, Quality and Operations. As a key member of our team, you will be responsible for developing and implementing the global CMC regulatory strategy for our development programs/products, ensuring compliance with manufacturing and quality control processes.", "ul": [{"li": "Develop and implement the global CMC regulatory strategy for Seqirus development programs/products, licenced through all development phases to registration/licensure and approval/post approval lifecycle stages."}, {"li": "In association with GRA Regions colleagues ensure CMC dossiers meet content requirements for applicable territories."}, {"li": "Lead sub-teams of regulatory and cross-functional experts to ensure author, preparation and compilation of high quality, submission ready CMC documentation for HA submissions in Seqirus territories."}, {"li": "Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes."}, {"li": "Provide strategic regulatory expertise and guidance for the development and review of technical protocols and reports."}], "h2": "Your Experience", "p": "To be successful in this role, you will have a tertiary degree in Biological Science, Allied Medical discipline or Pharmacy, with post-graduate qualifications or complementary experience in the pharmaceutical/biotechnology industry. You will also have 3+ years' regulatory experience with specific knowledge and experience in CMC, as well as excellent project management skills.", "ul": [{"li": "Tertiary Degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with post-graduate qualifications, or complementary experience in the pharmaceutical/ biotechnology industry."}, {"li": "3+ years' regulatory experience with specific knowledge and experience in CMC preferred."}, {"li": "Experience in a biologicals or biotechnology manufacturing environment e.g., QA, manufacturing or technical/product development advantageous."}, {"li": "Excellent project management skills"}], "h2": "What We Offer", "p": "At CSL, we're committed to providing a workplace that's respectful of your professional and personal lives, inclusive, and supportive of your career aspirations. We offer a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs that support your physical, emotional, financial, and social health and wellbeing.", "ul": [{"li": "A workplace that's respectful of your professional and personal lives — and inclusive, so you feel comfortable bringing your whole self to work."}, {"li": "Total rewards that include a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs, all of which support your physical, emotional, financial, and social health and wellbeing."}, {"li": "Career, performance and development programs that enable success in your current position and foster your development and growth."}], "h2": "About CSL", "p": "CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.", "p": "In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines.", "h2": "We Want CSL Seqirus to Reflect the World Around Us", "p": "As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.", "h2": "Do Work That Matters at CSL Seqirus", "p": "Watch our 'On the Front Line' video to learn more about CSL Seqirus."}
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Regulatory Affairs Specialist CMC
2 days ago
Parkville, Victoria, Australia 3085 Seqirus Pty Full timeJob Title: Principal Associate Regulatory Affairs CMCWe're seeking a highly skilled Principal Associate, Regulatory Affairs CMC to join our team at CSL Seqirus. In this strategic role, you will provide specialist strategic advice and support to Project/Product teams, Quality and Operations. Reporting to the local Head of GRA CMC, your main responsibilities...
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Regulatory Affairs Specialist CMC
4 days ago
Parkville, Victoria, Australia CSL Full timeKey ResponsibilitiesWe're seeking a highly skilled Principal Associate, Regulatory Affairs CMC to provide strategic advice and support to our Project/Product teams, Quality, and Operations. As a key member of our team, you will be responsible for developing and implementing the global CMC regulatory strategy for our development programs/products, ensuring...
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Parkville, Victoria, Australia CSL Full time**Mission and Objectives**Within the CSL Research and Development department, the mission of Global Pathogen Safety (GPS) is to develop and evaluate reduction strategies for viruses and other pathogens to provide products that our patients can trust and know to be safe.**Key Responsibilities**Define pathogen safety target profiles and establish a pathogen...
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Global Pathogen Safety Product Owner
1 week ago
Parkville, Victoria, Australia CSL Full timeJob SummaryCSL is seeking a highly skilled Senior Manager to lead the Global Pathogen Safety team in the development and evaluation of reduction strategies for viruses and other pathogens. The successful candidate will be responsible for defining pathogen safety target profiles, establishing a pathogen safety by design framework, and preparing submission...
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Global Pathogen Safety Product Owner
6 days ago
Parkville, Victoria, Australia CSL Full timeJob SummaryWe are seeking a highly skilled Senior Manager to lead our Global Pathogen Safety team. As the Product Owner for vaccine, recombinant, and cell and gene therapy-based products, you will be responsible for defining pathogen safety target profiles and establishing a pathogen safety by design framework based on Quality by Design principles.Main...
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Parkville, Victoria, Australia CSL Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Global Pathogen Safety Product Owner Recombinant to join our team at CSL. As a key member of our Research and Development department, you will play a critical role in developing and evaluating reduction strategies for viruses and other pathogens to ensure the safety of our products.Main...
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Senior Quality Assurance Specialist
2 weeks ago
Parkville, Victoria, Australia Evolve Scientific Full timeAbout the RoleEvolve Scientific is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesSelf-Inspection and Regulatory Compliance: Provide support for the preparation and...
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Validation Specialist
2 weeks ago
Parkville, Victoria, Australia CSL Full timeThe OpportunityCSL Seqirus, a global leader in influenza protection, is seeking a skilled Validation Specialist to join its Quality Assurance (QA) team. As a key member of the QA team, you will play a critical role in ensuring the quality and integrity of our manufacturing processes.The RoleAs a Validation Specialist, you will be responsible for:Performing...
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Validation Specialist
2 weeks ago
Parkville, Victoria, Australia CSL Full timeThe OpportunityCSL Seqirus, a global leader in influenza protection, is seeking a skilled Validation Specialist to join its Quality Assurance (QA) team. As a key member of the QA team, you will play a critical role in ensuring the quality and integrity of our products.The RoleAs a Validation Specialist, you will be responsible for:Performing validation...
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Virology Quality Assurance Specialist
1 week ago
Parkville, Victoria, Australia Healthcare Professionals Group Full time{"Benefits": "Enjoy a supportive and stable work environment with opportunities for growth and development.Collaborate with a global team of professionalsContribute to the success of a leading Biotechnology companyBe part of a dynamic and expanding company culture", "About the Company": "Healthcare Professionals Group is a global recruitment agency...
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Senior Quality Assurance Specialist
1 week ago
Parkville, Victoria, Australia Evolve Scientific Full time{"About the Role": "We are seeking a Senior Specialist to join our Site Inspections and Compliance team at Evolve Scientific. As a Senior Quality Assurance Specialist, you will be responsible for aspects of Self Inspections and regulatory inspection preparation and management/execution activities and support preparation and coordination of Quality Management...
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Parkville, Victoria, Australia Healthcare Professionals Group Full timeAbout the OpportunityThe Senior Specialist for Site Inspections and Compliance is responsible for ensuring the highest level of quality assurance and regulatory compliance within the organization. This role involves conducting audits and reviews to verify compliance with global GMP regulations and corporate requirements.Key ResponsibilitiesQuality Assurance...
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Senior Quality Assurance Specialist
2 weeks ago
Parkville, Victoria, Australia Evolve Scientific Full timeAbout Evolve Scientific:We are a leading pharmaceutical company dedicated to delivering high-quality products and services. Our team is passionate about ensuring compliance with global regulations and standards.Job Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our Site Inspections and Compliance team. As a key member of...
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Research Ethics Specialist, Animal Welfare
2 weeks ago
Parkville, Victoria, Australia University of Melbourne Full timeAbout the RoleThe University of Melbourne is seeking a highly skilled Research Ethics Specialist to join our Research, Innovation and Commercialisation (RIC) team. As a key member of our Ethics Shared Service model, you will play a critical role in providing administrative support for animal ethics submissions, ensuring compliance with relevant principles,...
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EHS Specialist
1 week ago
Parkville, Victoria, Australia CSL Full timeThe OpportunityCSL, a leading global biotechnology company, is seeking an experienced EHS Specialist to join their team. As a key member of the EHS department, you will be responsible for leading the development, implementation, and review of training programs, digital platforms, and EHS systems management to ensure organizational and regulatory...
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Aseptic Manufacturing Specialist
2 weeks ago
Parkville, Victoria, Australia 3085 Seqirus Pty Full timeAbout the RoleWe are seeking a skilled Aseptic Manufacturing Specialist to join our dynamic Influenza Virus Vaccine (IVV) team at our Parkville site. As a key member of our production team, you will contribute to the manufacture of vaccines using aseptic processes.Key ResponsibilitiesPrepare equipment for sterile manufacturing, ensuring adherence to cGMP...
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Medical Specialist
2 weeks ago
Parkville, Victoria, Australia Peter Mac Full timeAbout the RoleWe are seeking an experienced Melanoma and Sarcoma Surgeon to join our team at Peter Mac, a leading cancer research and treatment centre. As a key member of our surgical oncology team, you will be responsible for providing high-quality patient care, education, and research in the field of melanoma and sarcoma.Key ResponsibilitiesProvide...
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Senior Quality Specialist
2 weeks ago
Parkville, Victoria, Australia CSL Seqirus Full timeAbout the RoleAs a Senior Quality Specialist - External Supplier Management at CSL Seqirus, you will play a pivotal role in ensuring the quality and compliance of materials and services provided by Suppliers, Service Providers, Third Party Laboratories, 3PLs, Distribution Business Partners and Contract Manufacturers.You will develop, implement and maintain...
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EHS Specialist
1 week ago
Parkville, Victoria, Australia CSL Full timeThe OpportunityCSL, a leading global biotechnology company, is seeking an experienced EHS Specialist to join their team. As a key member of the EHS department, you will be responsible for leading the development, implementation, and maintenance of training programs, digital platforms, and EHS systems to ensure organizational and regulatory compliance.The...
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Validation Specialist
1 week ago
Parkville, Victoria, Australia CSL Full timeThe OpportunityCSL Seqirus, a global leader in influenza protection, is seeking a skilled Validation Associate to join our Quality Assurance (QA) Validation team in Parkville. As a key member of our team, you will provide validation support for process, cleaning, and equipment, as well as revalidation activities across the Seqirus business.The RoleBased...
