Senior Regulatory Affairs Specialist - 12 month contract at AstraZeneca

South Turramurra, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

0.0

Posted On

11 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, TGA Experience, Communication, Attention To Detail, Problem Solving, Cross-Functional Teamwork, CMC Changes, PI Changes, Regulatory Compliance, Regulatory Queries, Lifecycle Maintenance, eCTD Submissions, Rare Diseases, Specialty Pharmaceuticals, Patient Outcomes, Regulatory Strategies

Industry

Pharmaceutical Manufacturing

Description

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. Essential 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. Desirable 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). 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 11-Nov-2025 Closing Date 24-Nov-2025 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Lead end-to-end regulatory activities for timely registrations and optimal labelling across Australia and New Zealand. Collaborate with various teams to ensure compliance and respond to regulatory queries.