Assist in Regulatory Agency communications and submissions, including New Drug Applications (NDAs), investigational new drug (IND) applications, life cycle management/risk management plans and annual or other period reports Assist or take the lead in tracking, authoring, coordinating and/or review of responses to Agency requests Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications Act as primary Vifor RA representative in front of the TGA Maintain up-to-date regulatory intelligence on the local legislation, regulatory requirements and competitive intelligence, and communicate requirements to GRA and local staff. Develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc) in Australia Inform relevant management functions of industry trends and opportunities that impact Vifor portfolio and business. Collaborating and communicating regulatory strategy as needed to colleagues in GRA as well as other functional areas May provide oversight to regulatory consultants and vendors where applicable Support and approval maintenance (e.g. quality compliance and life cycle management) Maintain GRA archiving and tracking systems with local documents to ensure easy and quick access to all documents and transparency on activity status. Support the compilation, submission and maintenance of NDA, in alignment with RA International strategy. Review and approve product information, customer medicine information, labels and other documentation as required for local regulatory compliance Support the compilation, submission and maintenance of NDA, in alignment with RA International strategy. Review and approve product information, customer medicine information, labels and other documentation as required for local regulatory compliance Contribute to development of Vifor local Regulatory procedures and policies, including adapting global templates to local affiliate needs. Performing regulatory administrative activities, as needed Development and support of nanomedicine initiatives Participation and contribution to Medicines Australia industry working group Other duties as required
Minimum Requirements Registered Pharmacist is preferred Science degree or equivalent – biological (life) sciences (Pharmacology, biochemistry, physiology or closely related discipline), chemistry, pharmacy or equivalent Minimum 5 years of pharmaceutical (prescription drug) regulatory affairs experience in Australia and NZ Reviewing of technical reports Proficient in basic MS Word, PowerPoint and Excel knowledge of regulatory requirements in Australia and New Zealand Proven, first-hand experience of working in a fast-paced team environment Proven, first-hand experience of NDA submission in Australia and New Zealand Experience in working in a matrix organization and multidisciplinary team within the pharmaceutical industry Familiarity with the global regulatory environment and GxP regulations Preferred Requirements Experience in international GxP standards and / or experience in quality assurance functions in pharmaceutical, biotechnology, or medical device industries Experience in pharmacovigilance regulations and / or experience in Drug Safety and have some understanding of clinical development
About Us
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.
Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).