Head of Regulatory Affairs, ANZ
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; surgery products and anaesthetics; and pharmacy automation, software and 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.
What You’ll Be Doing
This high-profile role reports to the Head of RA Life Sciences – APAC and is also an integral part of the ANZ Leadership team. You will provide leadership and strategic direction to optimise the regulatory approval of new business opportunities and to ensure compliance of existing products with regulatory requirements both nationally and globally.
• Effective management of the Company’s regulatory affairs and change strategy
• Lead and design the strategy for the management of all regulatory relationships and regulatory change across ANZ
• Design and implement regulatory frameworks and policies and be the key liaison point for all regulatory enquiries across the organisation
• Lead discussions with respective Boards on the impacts of regulation and regulatory change including making critical recommendations on future on future strategic direction for the Boards and Leadership teams
• Maintain involvement and collaborate with government bodies, ensuring that regulatory submissions meet appropriate standards and content requirements
• Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and contingency plan
• Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support ongoing registration activities
• Interact with global regulatory functions to attract research to Australia/New Zealand
• Position Baxter Healthcare ANZ as a key stakeholder in global regulatory initiatives to ensure adequate and timely support is needed.
• Lead a team of Regulatory professionals to drive high performance across the business unit
• Ensure that the RA team members are skilled and kept up to date with changes to regulations and standards and advise local, regional and global colleagues of the impacts of such changes
Do you have what it takes to build a career here?
• Tertiary qualifications in Pharmacy or Biological Sciences – ideal
• Post graduate qualifications in Business or related area – advantage
• Minimum of 10 years’ experience in Regulatory Affairs in the Australian pharmaceutical industry, covering drugs, devices and biologicals
• Proven and established relationships with regulatory authorities
• Demonstrated negotiation skills and sound experience in interacting with regulatory authorities
• Relationship Building & Stakeholder Management - the ability to build strong and positive relationships with executive stakeholders both internally and externally
• Ability to think strategically, evaluate risks and advise/educate the local business on these risks
• Business / Commercial acumen – ability to use information about organisational climate and key individuals to accomplish legitimate organisation goals
• Leadership & Team Building – demonstrated ability to lead, develop and coach teams
• Executive level interpersonal skills (written and verbal)
• Planning and Organising - able to prioritise and develop realistic action plans and manage organisational change
• Ability to work autonomously with a drive and determination to succeed
Why Baxter? A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
For further information, please contact Charlotte Williams on (02) 9848 1236.
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law