About the job

Are you a regulatory specialist and have a passion for seeing patients have access to life changing medicines? Would you like to apply your expertise to help turn our rare disease pipeline into reality? Then AstraZeneca, Alexion might be the one for you!

About Alexion

As a business, we are committed to people. Everyone goes above and beyond to overcome significant challenges and achieve extraordinary outcomes. Our patient first approach informs all our decision-making, and we invest in team and individual development. Ours is an energetic, fast-paced way of working that is solutions focused and collaborative.

We will help you expand your skills and knowledge and unlock your best. Working at pace, you’ll be challenged and supported to grow – learning from inspiring leadership and exceptional teams who believe in the power of science to make a difference. Every day you will broaden your horizons and skills, finding opportunities to take the initiative and build a meaningful career. Our outstanding learning resources and new diverse career-enhancing opportunities will quickly deepen your personal and professional growth.

**Why Alexion? **

At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translate into innovative breakthroughs for patients.

• Growth & Opportunity: Be part of a growing team with opportunities to shape strategy and make a meaningful impact on patient care.
• Launch Excellence: Work on high-profile launches, supporting the introduction of innovative therapies to the Australian market.
• Collaborative Culture: Join a supportive, resilient team that values fresh perspectives, encourages a can-do attitude and provides mentorship to new team members.

BUSINESS AREA

Within our Regulatory and Quality Affairs (RQA) team, an exciting opportunity has become available for a newly created Senior Regulatory Affairs Specialist. The RQA team is gearing up for an exciting future, with product submissions across all rare disease therapy areas. In this role, you will prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand. You will demonstrate in-depth knowledge of regulatory affairs submissions and contribute to business improvement and compliance activities within the Regulatory Affairs Department.

What You’ll Do

As a Senior Regulatory Affairs Specialist, you will provide regulatory input to the development of business strategic and tactical plans. Deliver effective and commercially advantageous regulatory plans for product submissions, with the aim of attaining an optimum label and earliest commercial launch.

Essential For The Role

• Science related tertiary qualifications
• Significant experience in a (Senior) Regulatory Affairs role from within the pharmaceutical industry in Australia/New Zealand
• Experience preparing Category 1 applications of new biological entities
• Working relationships with the TGA and/or Medsafe and other relevant government agencies
• Demonstrated successes in building strong external and internal relationships through effective communication, influencing and collaborative networking skills
• Strong attention to detail, resilience and an ability to bring innovative ideas to problem solving
• Leadership skills including experience in leading cross-functional projects or teams