Senior Regulatory Affairs Associate
2 weeks ago
Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipeline into reality? Then AstraZeneca might be the one for you ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Our leadership style is progressive. Resolutely committed to our collective success, leaders foster high performance and strong team connections, aware of different ways of working and the need for work-life balance. Our leaders live our Purpose and Values, encouraging open communication between all levels of the organisation and empowering teams so they can thrive. BUSINESS AREA Within our Regulatory Affairs (RA) team, an exciting opportunity has become available for a Senior Regulatory Affairs Associate. The RA team is gearing up for an exciting year, with major product submissions across all our therapy areas. In this role, you will prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand. You will demonstrate in-depth knowledge of regulatory affairs submissions and contribute to business improvement and compliance activities within the Regulatory Affairs Department. What you'll do This role is an opportunity for an experienced pharmaceutical regulatory affairs professional keen to move into a global organisation with a strong pipeline in Oncology, Cardiovascular, Immune Therapies and Respiratory. As a Senior Regulatory Affairs Associate you will provide regulatory input to the development of business strategic and tactical plans. Deliver effective and commercially advantageous regulatory plans for product submissions, with the aim of attaining an optimum label and earliest commercial launch. Essential for the role Science related Tertiary qualifications Experience in a (Senior) Regulatory Affairs role from within the pharmaceutical industry in Australia/New Zealand Experience preparing category 1 applications Working relationships with the TGA and/or Medsafe and other relevant government agencies Demonstrated successes in building strong external and internal relationships through effective communication, influencing and collaborative networking skills Strong attention to detail, resilience and an ability to bring innovative ideas to problem solving Leadership skills including experience in leading cross-functional projects or teams Desirable for the role An understanding of biological medicines such as monoclonal antibodies New chemical entity/new biological entity application/submission experience preferable Why AstraZeneca At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare. Part of an inclusive and giving community, we support and help each other on our journeys – backed by the same personal commitment to each other as we give to patients. Curious problem solvers, we are intellectually stimulated by constant learning. There's potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities. AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI). So, what's next Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have a seat available, and we hope it's yours. Please note that all internal applications must be accompanied by a Talent Card. Please see link to assist you with creating your Talent Card. If you're curious to know more, please contact Dia Dutta. Where can I find out more? Visit AZ Careers Page Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram #J-18808-Ljbffr
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Senior Regulatory Affairs Associate
2 weeks ago
Auckland, New Zealand Astrazeneca Gmbh Full timeDo you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipeline into reality? Then AstraZeneca might be the one for you! ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that...
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Senior Regulatory Affairs Associate
2 weeks ago
Auckland, New Zealand Astrazeneca Gmbh Full timeDo you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipeline into reality? Then AstraZeneca might be the one for you!ABOUT ASTRAZENECAAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that...
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Regulatory Affairs Associate
5 months ago
Auckland City, New Zealand Elanco Full timeEducation : EQUIVALENTEXPERIENCE **As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeAbout the Role As designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of standards, regulations and guidelines mandated by regulatory authorities. Our Regulatory Affairs team is critical to our success ensuring that our devices are designed to meet regulatory requirements, are accepted in market,...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeCompany description:Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care. Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year.Job description:About...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeAbout the RoleAs designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of standards, regulations and guidelines mandated by regulatory authorities.Our Regulatory Affairs team is critical to our success ensuring that our devices are designed to meet regulatory requirements, are accepted in market,...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeAbout the RoleAs designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of standards, regulations and guidelines mandated by regulatory authorities.Our Regulatory Affairs team is critical to our success ensuring that our devices are designed to meet regulatory requirements, are accepted in market,...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeCompany description: Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care.Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year.Job description: About...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeCompany description:Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care. Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year.Job description:About...
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Auckland, New Zealand Fisher & Paykel Healthcare Full timeCompany description: Our story began more than 50 years ago, when one doctor and two engineers designed a better way to care. Today, we are a thriving global business, and our products, used in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea, make a difference to millions of patients every year. Job description: About...
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Regulatory Affairs Specialist
3 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs SpecialistLocation: Auckland, NZ-AIA New ZealandTime Type: Full timePosted On: 2 Days AgoJob Requisition ID: JR-52807At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
2 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs SpecialistLocation: Auckland, NZ-AIA New ZealandTime Type: Full timePosted On: 2 Days AgoJob Requisition ID: JR-52807At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
3 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs SpecialistLocation: Auckland, NZ-AIA New ZealandTime Type: Full timePosted On: 2 Days AgoJob Requisition ID: JR-52807At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
2 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs SpecialistLocation: Auckland, NZ-AIA New ZealandTime Type: Full timePosted On: 2 Days AgoJob Requisition ID: JR-52807At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
2 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs Specialist Location: Auckland, NZ-AIA New Zealand Time Type: Full time Posted On: 2 Days Ago Job Requisition ID: JR-52807 At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
3 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs Specialist Location: Auckland, NZ-AIA New Zealand Time Type: Full time Posted On: 2 Days Ago Job Requisition ID: JR-52807 At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Specialist
2 weeks ago
Auckland, New Zealand Aia Hong Kong And Macau Full timeRegulatory Affairs Specialist Location: Auckland, NZ-AIA New ZealandTime Type: Full timePosted On: 2 Days AgoJob Requisition ID: JR-52807At AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live....
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Regulatory Affairs Professional
4 weeks ago
Auckland, Auckland, New Zealand Fisher & Paykel Healthcare Full timeAbout the RoleFisher & Paykel Healthcare is seeking a highly skilled Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring our medical devices meet regulatory requirements and are accepted in the market.Key ResponsibilitiesConduct...
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Regulatory Affairs Specialist
3 weeks ago
Auckland City, New Zealand AIA Full timeAt AIA we’ve started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live. Encompassing our ambition of helping a billion people live Healthier, Longer, Better Lives by 2030. And to get there, we need ambitious...
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Regulatory Affairs Specialist
2 weeks ago
Auckland, New Zealand Aia Full timeAt AIA we've started an exciting movement to create a healthier, more sustainable future for everyone. It's finding new ways to not only better people's lives, but to better the communities and environments we live. Encompassing our ambition of helping a billion people live Healthier, Longer, Better Lives by 2030. And to get there, we need ambitious people...
