Regulatory Affairs Specialist

5 months ago

Old Toongabbie, Australia BAXTER Full time

**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.

**About Baxter**

Baxter provides a broad portfolio of essential Renal and Hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; Advanced Surgery products and anaesthetics; and pharmacy automation, software and compounding services.

The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Driven by our culture and our values, we lead with insights, ideas and outcomes meaningful to our business success. We are experts in our field, and we continue to learn and grow every day, striving to learn more about our customers and the world around us. Our way of working is open and collaborative with a focus on building trusted and ongoing relationships with all stakeholders.

**The Role**

The Regulatory Affairs Specialist will play a critical role in our Advanced Surgery business and working with the team you would be managing activities such as obtaining and maintaining marketing authorizations for products in Australia and New Zealand (ANZ) and communication of general regulatory requirements in support of licensing of Baxter’s products.

Role responsibilities include (but not limited to):

- Supports regulatory project plan execution
- Maintain awareness of regulatory requirements and ensure continued learning
- Maintain regulatory files in a format consistent with requirements
- Participate as an active team member of project teams as required
- Compile and prepare responses to questions from regulatory authorities according to plan
- Edit and proofread regulatory documentation
- Assist in preparation and review of labeling, SOP’s, and other departmental documents
- Compile under supervision regulatory documents for submission
- Uses the Regulatory Information Management system for registrations, submissions and associated lifecycle management of regulatory data
- Track status and progress of regulatory documentation
- Prepare and review AdProm materials for compliance with local regulations

**About You**

To be successful in this role you will be an experienced Regulatory affair professional with the ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment. You will also have strong Negotiation skills and experience in interacting with regulatory authorities, industry associations, internal and external stakeholders. You work well in a constantly changing environment and enjoy managing multiple projects and deadlines.
- Exercise independent judgment
- Knowledge of regulations
- Scientific knowledge
- Administrative and project management skills
- Strong Interpersonal, communication, Proofreading and editing skills

**Qualifications and Experience**:

- Bachelor’s degree in science, in a relevant scientific discipline; postgraduate qualifications in a relevant scientific discipline will be an advantage
- Minimum of 2-year regulatory experience in RA or equivalent experience within a medical device and/ or pharmaceutical

**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.

We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for delivering support structures for working families; stronger actions to address pay inequalities; and

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