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This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You''ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter''s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.The RoleAn exciting opportunity has arisen for a Regulatory Affairs Manager to join our Baxter ANZ QARA team to lead product registration and compliance in Australia and New Zealand. In this role you will work on improving business outcomes by prioritizing and accelerating the registration of company products. You will maintain marketing authorizations of existing products and ensure compliance with applicable laws and regulations in Australia and New Zealand.ResponsibilitiesCommunicate ANZ submission requirements to relevant regional and global collaboratorsKeep the QARA leadership team informed of application progress and issues impacting complianceDevelop and implement regulatory strategy aligned with business strategyImplement policies to ensure ongoing compliance with regulatory requirementsCoordinate the Quality Systems program to ensure timely implementation of Corporate standards and proceduresEnsure the efficiency of the Management review process and monthly reviews for the Manager with Executive Responsibility (MWER)Represent the Company in day-to-day quality matters with employees, visitors, contractors, and external sources such as Government agenciesProvide direct supervision, mentoring, performance management, and staffing decisionsSupport ongoing marketing strategies by registering new products meeting corporate/business requirementsMaintain marketing authorizations for existing productsCompile and submit regulatory submissions in a timely mannerEnsure maintenance of licenses and permits where applicableIdentify optimization procedures and develop guidelines as neededEnsure staff are trained in regulatory matters based on current standards and guidelinesDevelop relationships and liaise with Industry associates and government officers to facilitate the company''s businessKeep up to date with regulatory changes and advise colleagues on implicationsReview existing procedures and databases with Regulatory staff, implementing beneficial improvements.Key requirements:Tertiary degree in Pharmacy or a related scientific fieldsMinimum of 8 years of experience in Regulatory Affairs in the Australian/New Zealand pharmaceutical industry is required for this roleProven experience in working closely with the TGAProven people management experienceExtensive background in technical problem-solvingSolid scientific knowledge baseExpert knowledge of regulatory regulations and guidelinesEstablished relationships with regulatory authoritiesStrong risk identification and problem-solving skillsExtensive experience engaging with regulatory authorities, industry associations, and collaboratorsAnalyzing and assessing regulatory activities with a focus on critical evaluation skillsExperience in process improvement within a Quality environment.Why Baxter?At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively. Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives.Baxter is proud to be recognized as an Inclusive Employer by the Diversity Council of Australia. We are also committed to delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of all people at work.Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.#li-baxgen#ind-anzReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. #J-18808-Ljbffr