Manager, Regulatory Affairs

1 week ago

Old Toongabbie, New South Wales, 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
This role reports into the Global Regulatory Affairs, Senior Director.

As the Regulatory Affairs Manager, you will be responsible/accountable for defining the regulatory strategies and all the operational aspects of regulatory submissions, in support of new and existing marketing authorizations for the Advanced Surgery portfolio in Australia and New Zealand.


The Regulatory Manager will also be responsible for overseeing regulatory plans and strategies for Advanced Surgery within the APAC region (except Japan and China).


The Regulatory Manager will provide instrumental regulatory support to the Advanced Surgery commercial business operations within the region, working closely with the APAC commercial lead, as well as providing specific support to the ANZ commercial organization.


Role responsibilities include (but not limited to):

  • Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products in ANZ
  • Develop and execute regulatory plans and strategies for APAC region (excluding Japan and China)
  • Identify & prioritize key areas of risk and develop & implement appropriate mitigation plans
  • Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
  • Perform gap analysis on regulatory documentation and propose solutions. Identify areas for improvement
  • Develop and document sound regulatory decisions and justifications and manage communication with ANZ regulatory authorities
  • Establish appropriate communication within RA, with local Marketing, and with other functions primarily at project level and favor proactive communication
  • Ensure regulatory strategy and deliverables are aligned with project teams and business objectives
  • Lead regulatory activities related to the Advanced Surgery portfolio of products
  • Prepare, review, and approve labeling, SOPs and AdProm materials for compliance with ANZ regulations.
  • Responsible for all operational aspects related to the use of the Regulatory Information Management system (including; registrations, submissions and associated lifecycle management of data within the system)
  • Represent or lead the RA function on assigned crossfunctional project teams
  • Oversee and coordinate Advanced Surgery regulatory actions in APAC (excluding Japan and China)
  • Represent Regulatory Affairs as a Member of the Advanced Surgery VP of APAC's leadership team.

About You


To be successful in this role you will be a senior Regulatory affairs 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.

  • Ability to multitask and prioritize
  • Ability to work effectively in multinational/multicultural environment
  • Sound understanding

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