Senior Regulatory Affairs Specialist

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

So, what’s next?   

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. 
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. 
• If you’re curious to know more then please reach out to Danielle Jones.  We welcome your application.
   

Where can I find out more? 
Our Social Media, Follow AstraZeneca on LinkedIn

Visit https://www.astrazeneca.com.au/ and https://www.astrazeneca.com/

For some useful hints and tips, please visit https://careers.astrazeneca.com/application-hints-tips
 

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.