Regulatory Affairs Manager, ANZ

This is where you save and sustain lives

At 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 lives—where your purpose accelerates our mission.

The Role

An 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.

Responsibilities

• Communicate ANZ submission requirements to relevant regional and global collaborators

• Keep the QARA leadehip team informed of application progress and issues impacting compliance

• Develop and implement regulatory strategy aligned with business strategy

• Implement policies to ensure ongoing compliance with regulatory requirements

• Coordinate the Quality Systems program to ensure timely implementation of Corporate standards and procedures

• Ensure 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 agencies

• Provide direct supervision, mentoring, performance management, and staffing decisions

• Support ongoing marketing strategies by registering new products meeting corporate/business requirements

• Maintain marketing authorizations for existing products

• Compile and submit regulatory submissions in a timely manner

• Ensure maintenance of licenses and permits where applicable

• Identify optimization procedures and develop guidelines as needed

• Ensure staff are trained in regulatory matters based on current standards and guidelines

• Develop relationships and liaise with Industry associates and government officers to facilitate the company's business

• Keep up to date with regulatory changes and advise colleagues on implications

• Reviewing existing procedures and databases with Regulatory staff, implementing beneficial improvements.

Key requirements:

• Tertiary degree in Pharmacy or a related scientific fields

• Minimum of 8 years of experience in Regulatory Affairs in the Australian/New Zealand pharmaceutical industry is required for this role

• Proven experience in working closely with the TGA

• Proven people management experience

• Extensive background in technical problem-solving

• Solid scientific knowledge base

• Expert knowledge of regulatory regulations and guidelines

• Established relationships with regulatory authorities

• Strong risk identification and problem-solving skills

• Extensive experience engaging with regulatory authorities, industry associations, and collaborators

• Analyzing and assessing regulatory activities with a focus on critical evaluation skills

• Experience 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 an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.

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.

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Reasonable Accommodations

Baxter 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.

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