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
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا