Senior Manager Regulatory Affairs – Australia - Innovator Pharmaceutical Products (Melbourne)

Lieu: Australia - Melbourne

Fonction: Regulatory Affairs

Niveau de Séniorité: Senior Manager

Votre profil

Vifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, we are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. A newly created role has arisen within the Australian business to support upcoming multiple first registrations for innovative products with clear unmet clinical needs.
Reporting to the GM of Australia you will be a seasoned regulatory professional with a track record of successful strategic competency within Australian Regulatory Affairs, leading registration with health authorities (TGA) and regulatory intelligence and advocacy activities to ensure optimal outcomes for Vifor Pharma and the patients we serve. Ideally you will have experience with Orphan or Rare disease products and have collaborated internally on reimbursement activities. 

  • 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

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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