About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. We have an exciting opportunity for a full-time Senior Regulatory Affairs Associate to join the ANZ team based in Mascot. Planning and management of major submissions to register NCEs or new indications to existing products within an assigned product portfolio Planning and management of variation applications for assigned products Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures Manage interactions with TGA and Medsafe and maintain productive working relationships with these authorities to optimize regulatory outcomes Develop and maintain an up-to-date working knowledge of the compounds, diseases and competitors relevant to the product portfolio Maintain good working knowledge of relevant regulatory guidelines and procedures Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager Maintain excellent cross-functional relationships with key global regulatory personnel and affiliate medical, commercial, operations and market access contacts to ensure cohesive stakeholder management and affiliate support Support the commercialisation of products through participation in local brand teams Provide comment on TGA/Medsafe consultation documents as required Qualifications Education/Experience Required: 5 years regulatory affairs experience in pharmaceutical or biotech industry Working experience with multinational company Experience with new drug applications Familiar with regulatory guidelines and requirements Essential Skills & Abilities: Good written and oral communication skills Excellent attention to detail Ability to work autonomously as well as part of a cross function team Ability to critically appraise data A commercial focus and a desire to contribute to the overall success of the business Leadership Attributes: All for One AbbVie Clear and Courageous Decide Smart and Sure Agile and Accountable Make Possibilities Real Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.