Regulatory Specialist: Pharmaceutical Submissions
4 days ago
About the opportunity
This role focuses on established products and offers a unique mix of submission responsibility, strategic contribution, and cross-functional collaboration.
Duties:
- Prepare and manage submissions for new licenses, renewals, variations, PSURs, DSURs, and post-approval changes.
- Lead preparation of documentation for health authority meetings on mature products.
- Liaise with Global Regulatory Leads, providing local and regional input.
- Submit all regulatory documentation to Health Authorities in a timely, compliant manner.
- Respond to health authority queries and manage preparation of answers to both basic and complex regulatory questions.
- Independently file CAT 1 and CAT 3 applications under TGA requirements.
Requirements:
- Bachelor's degree in Biological or Medical Science, Pharmacy, or a related field. Postgraduate studies in Regulatory Affairs are a strong advantage.
- Minimum 3+ years' experience in a regulatory affairs role with a focus on pharmaceuticals.
- Minimum 3 years experience in CAT 1/CAT 3.
- Strong knowledge of TGA requirements and regulatory frameworks.
- Understanding of GMP, GCP, and GLP.
- Confident communicator who can collaborate across teams and influence decision-making.
- Strategic and solution-oriented mindset with excellent attention to detail.
Culture
We foster a supportive, high-performance culture where initiative is recognised and regulatory professionals are seen as strategic business partners.
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