Senior Regulatory Affairs Specialist - 12 month contract

• 12 Month Fixed Term Contract (potential to go perm)
• Macquarie Park Location - Free on-site parking, close to Metro
• Hybrid - 2 days WFH, 3 days office based
• Full Time or 4 days also considered

Join a team with the courage to change the course of rare disease At Alexion, AstraZeneca Rare Disease, we are united by a bold mission: to transform the lives of people living with rare diseases. We’re seeking a highly capable and delivery-focused Senior Regulatory Affairs Specialist to lead end-to-end regulatory activities across Australia and New Zealand—enabling timely registrations, optimal labelling, and seamless lifecycle maintenance that ultimately benefits patients.

What you’ll do

As a Senior Regulatory Affairs Specialist with strong TGA experience and a passion for improving patient outcomes, you will:

• Regulatory strategy: Drive timely approvals and competitive labels aligned to business and patient needs.
• CMC and labelling: Lead CMC changes and PI/CMI updates with quality and compliance.
• Cross‑functional partnership: Collaborate with Medical, Commercial, PV, Quality, and Global Regulatory to align plans and manage risks.
• Health authority engagement: Lead TGA/Medsafe interactions and worksharing pathways; manage queries end‑to‑end.
• Submissions: Deliver high‑quality eCTD dossiers for registrations, variations, safety updates, renewals, and post‑approval commitments.
• Intelligence and compliance: Track regulatory changes; turn insights into clear actions and maintain robust documentation.

Essential for the role

• Bachelor’s degree in Science or related discipline.
• 3–5 years’ experience in pharmaceutical regulatory affairs for prescription medicines.
• Proven TGA regulatory expertise and strong knowledge of Australian regulatory frameworks and processes.
• Hands-on experience with eCTD submissions and lifecycle management.
• Strong communication, meticulous attention to detail, sound judgment, and proactive problem-solving.
• Demonstrated ability to work effectively within cross-functional and matrixed teams.

Desirable

• Experience in rare diseases or specialty pharmaceuticals.
• Familiarity with New Zealand Medsafe processes and ANZ worksharing pathways.
• Experience supporting CMC variations and complex labelling negotiations.
• A genuine passion for improving patient outcomes in underserved populations.

Why Join Alexion, AstraZeneca Rare Disease?

You will join a purpose-led, high-performing team recognized as a Great Place to Work, where your expertise is valued and your voice is heard. We offer an inclusive culture built on integrity, collaboration, and innovation—where you can do the best work of your career while making a meaningful difference for patients.

We celebrate diversity and inclusion AstraZeneca in Australia is an Employer of Choice for Gender Equality (WGEA). We are committed to building high-performing, inclusive, and diverse teams with pay equity, leadership development, and zero tolerance for gender-based harassment. We welcome and consider applicants from all backgrounds, and we value diverse perspectives that help us innovate for patients.

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 accommodations@Alexion.com. Alexion participates in E-Verify.