Sydney, New South Wales, Australia
STADA Pharmaceuticals Australia is a specialty prescription pharmaceutical and consumer healthcare company, operating as part of the global STADA Group, which supplies high‑quality medicines to around 120 countries. Since 2016, the organisation has provided treatments for chronic and serious medical conditions across Australia and New Zealand, with a strong focus on Parkinson’s disease and other neurological areas. Through initiatives such as the STADA Nurse Advisor Service, the company supports healthcare professionals, patients, and families with high‑quality guidance and care. STADA’s purpose — Caring for people’s health as a trusted partner — underpins its expansion into new therapeutic areas and its commitment to improving health outcomes in the region. In my role as Manager Regulatory Affairs, Pharmacovigilance & Quality, I oversee the regulatory lifecycle of STADA’s prescription medicines and consumer healthcare products in Australia and New Zealand. I manage submissions and approvals with the TGA and Medsafe, ensure ongoing compliance with regulatory and quality standards, and maintain robust pharmacovigilance systems to monitor product safety. I work closely with global and local stakeholders to support product launches, lifecycle management, audits, and quality processes, ensuring that all activities meet both corporate and regional requirements.
- Regulatory compliance, portfolio maintenances and new product registrations. Responsible person for STADA ANZ portfolio in Specialty Pharma, CHC, Medical Devices. - Responsible person Quality Assurance, Pharmacovigilance, Device Vigilance - Market Access (PBS listings)
Medlab Clinical is an Australian biotechnology company (NASDAQ:MDLB; ASX:MDC) that is developing therapeutics using its proprietary, next-generation delivery platform, NanoCelle®. Medlab supplies two medicinal cannabis products via the Special Access Scheme (SAS) and the Authorised Prescriber Scheme in Australia, NanoCelle® NanaBis (1:1 THC:CBD, cannabis oil based) and NanoCelle® NanoCBD (CBD only, hemp based). Medlab seeks formal drug registration for both products: NanaBis via the FDA NDA 505(b)(2) pathway (Fixed-dose-combination), and NanoCBD via the TGA Over-the-counter Medicine Registration (S3) pathway (N5 New non-generic medicine). The drug candidates for formal drug registration will utilise synthetic cannabinoids (synthetic cannabidiol and dronabinol) and are therefore no medicinal cannabis products per definition. Role and responsibilities: - Responsible for the Regulatory part of Medlab’s pharmaceutical drug development program (NanaBisTM [synthetic] and NanoCBDTM [synthetic]: FDA NDA 505(b)(2) for NanaBisTM and TGA Over-the-counter Medicine Registration (S3) for NanoCBD) - Liaising with TGA and FDA. FDA Pre-IND meeting NanaBis; TGA submission meeting NanoCBD On-boarding US based pharmaceutical drug manufacturer for NanaBis and NanoCBD Leading Medlab’s NanaBis FDA IND application (PIND 139505) Preparation of a Common Technical Document (CTD) for NanaBis: o Writing the Quality part (Module 3 and Module 2.3) o Advising on and reviewing the clinical and non-clinical parts (Modules 4, 5, 2.4 and 2.5) o Regulatory guidance on clinical trial design and non-clinical requirements according to FDA and ICH guidelines.
- Supervision of a Quality Assurance Officer and regular staff and compliance training - Setting up and building the regulatory framework for Medlab’s distribution facility for S4 and S8 drugs (facility design, procedures, compliance training of staff as well as licensing) - Generating SOPs (Australian code of good wholesaling practice for medicines S4 and S8) - Responsible for the correct handling of controlled drugs (S8) in the R&D lab and warehouse - Quality Control of all incoming goods from manufactures and internal release for supply prior to distribution from Medlab’s warehouse to end-user (VMS/complementary medicines and S4/S8 drugs). -Customer complaints (quality) and liaising with manufacturer to resolve issues - Apply and maintain Medlab’s NSW Health “Licence to Supply and Wholesale” (S4 and S8 drugs) for the distribution facility - Apply for and maintain Medlab’s NSW Health “Authority to Possess or Supply Schedule 8 or Schedule 9 Substances for the Purpose of Research” for the R&D lab - QA/QC of Medlab's OGTR registered PC2 facility Successful Completion of NATA training: Understanding NATA's ISO/IEC 17025 Requirements (Certificate No 09307)
- Head of a team of 4 Regularly Affairs and Quality Associates - Give regulatory guidance to the Executive team. - Responsible for the regulatory compliance of Medlab’s Medicinal Cannabis Program (TGO93, TGO100, TGO95): NanoCelle® NanaBisTM (1:1 THC:CBD, cannabis oil based) and NanoCelle® NanoCBDTM (CBD only, hemp oil based) - Responsible for the regulatory support for Medlab’s Complementary Medicine Section (up to 20 product listed on the ARTG) - Ensure all products meet FSANZ and TGA requirements - ARTG Listings and TGA ebs system - Evidence Lists VMS products - New Product Development – formulation development und advice on therapeutic claims - Labels and Advertisement (TGA Advertisement Code) - TGA Section 31 requests - Import permit for bulk and finished products (Department of Agriculture, BICON) - Pharmacovigilance – set up and maintain Medlab’s AE recording platform in compliance with TGA’s “Pharmacovigilance responsibilities of medicine sponsors” - Liaise with manufacturer: o New manufacturer: Quality-and Service Agreements, on-boarding and technology transfer o Existing manufacturer: Liaise and maintain good relationship. Primary contact for all Regulatory or Quality related questions
Vaccine Lot Release, category 3 applications (Prescription Medicine) Good knowledge of Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 Reading, understanding and reviewing of Quality Management System documents and manufacturing protocols, reviewing of packaging, labeling and PIs Laboratory/R&D: Quality testing vaccines, ELISA, Development of protocols and SOPs to analyse particle contamination in vaccines by FlowCAM Training and Education: 1-days-workshop: Legal Awareness Training - Good Decision Making Webinar: Immunological Mechanisms of Vaccine-elicited Protection: Licensed Vaccines 1-days-workshop: Legal Awareness Training - Writing Statements of reasons 1-day Training: Training on the correct use of the FlowCam® VS Series Dynamic Imaging Particle Analyser
-Good Documentation Practice, QA/QC -NATA and ISO 17025 regulations -ELISA -FACS, cell counting, cell viability -Handling of human, equine and canine stem cells -PRISM GraphPad (2D graphing and statistics software)
-Consulting in scientific/biosafety/regulatory issues -Administrator Project Portfolio Management System (PPMS) (online equipment booking system) -Hands-on experience with chemical database: .ramp (RFID technology) -Assisting the team with organisational and management duties, e.g.supplier liaision, waste management, WH&S issues, -80 freezer maintenance