Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist - 12 month contract

Are you ready to make a difference for people living with rare diseases? Join a purpose-led team advancing innovative medicines for patients. We're seeking a highly capable and delivery focused Senior Regulatory Affairs Specialist for a 12‑month fixed-term contract to lead end-to-end regulatory activities that enable timely registrations, optimal labelling, and seamless lifecycle maintenance across Australia and New Zealand.

What you'll do

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

- Develop and implement regulatory strategies that enable timely approvals and commercially advantageous labels.
- Provide expert regulatory input into CMC and PI changes.
- Collaborate with medical affairs, commercial, and global regulatory colleagues to align strategies and ensure compliance.
- Respond to regulatory queries and maintain relationships with regulatory authorities.
- Monitor evolving regulatory landscapes to identify opportunities and mitigate risks.
- Bachelor's degree in Science or related field.
- 3-5 years' experience in pharmaceutical regulatory affairs (prescription medicines).
- Proven TGA regulatory expertise and knowledge of Australian frameworks.
- Experience with eCTD submissions.
- Strong communication, attention to detail, and problem-solving skills.
- Ability to work effectively in cross-functional teams.
- Experience in rare diseases or specialty pharmaceuticals.
- A genuine passion for improving patient outcomes.

About AstraZeneca & Alexion Rare Disease

AstraZeneca is a global, science-led biopharmaceutical company focused on transforming treatment across Oncology, Cardiovascular, Renal and Metabolism (CVRM), Respiratory & Immunology (R&I), and Rare Disease.
Alexion, AstraZeneca Rare Disease drives innovation-pushing the boundaries of science and working alongside clinicians to redefine what is possible for patients living with rare diseases.

Why Join Alexion, AstraZeneca Rare Disease?

At Alexion, we are committed to making a difference through our bold mission: transforming the lives of people living with rare diseases. Recognized as a Great Place to Work, our team welcomes talented, diverse individuals who thrive in a collaborative environment. Here, your voice is heard, your expertise is valued, and your work truly changes lives.

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) and as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

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