Regulatory Affairs Expert Wanted
We are seeking a seasoned Regulatory Affairs professional to join our team. As a Regulatory Affairs Manager, you will be responsible for leading and managing regulatory activities across our product portfolio.
About the Role
* Prepare, review, and submit regulatory applications and dossiers to health authorities (TGA, Medsafe, PBAC, PHARMAC).
* Monitor marketing application progress and maintain licenses for imported goods.
* Analyse scientific content of registration packages to ensure regulatory compliance.
* Liaise with government departments and consultants to facilitate product approvals and reformulations.
* Negotiate with regulatory bodies on product information, storage, shipment, and quality standards.
* Respond to investigations and queries related to product integrity, packaging, and storage.
* Review and approve promotional materials in line with Medicines Australia's Code of Conduct.
* Support phase 3 clinical trials by managing CTNs and liaising with the TGA and CROs.
* Lead internal audits and represent the affiliate in global QA forums.
* Maintain SOPs, Crisis Management documentation, and Risk Management Plans.
* Provide training to new employees on regulatory processes and requirements.
* Monitor regulatory changes and assess business impact.
Your Background
* Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or Regulatory Affairs (Master's preferred).
* 3–5 years' experience in Regulatory Affairs within the pharmaceutical, biotech, or healthcare industry.
* Strong understanding of Australian and New Zealand regulatory environments.
* Proven success in regulatory submissions and product approvals (Category 1 and 2).
* Strategic thinker with excellent analytical, negotiation, and communication skills.
* Experience in neuro rare or rare disease regulatory submissions is highly desirable but not essential.
Our Offer
We offer an inspiring workplace and innovative culture, where our curiosity, accountability, and adaptability enable us to transform lives. We aim to accelerate progress in addressing the big unmet needs of people living with brain disorders, offering rewarding careers with a mix of exciting tasks and development opportunities balanced with well-being initiatives.