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regulatory affairs - melbourne.

job details

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    job details
    Randstad has been given the opportunity to support one of our flagship clients in the Pharmaceutical space, who are currently recruiting a key position of Regulatory Affairs Project Manager, to be based in central Melbourne. This role gives you the opportunity for progression within this growing organisation, dealing with national and International teams, based from the client's site here in central Melbourne. Also offering the opportunity to work from home with flexibility and a package of $120-$140k + super depending on experience. The main purpose of the role is to support the International Regulatory Affairs management team across the wider business, with key focus on -
    • Preparation and submission of marketing authorization applications in International markets, including Australasia, Europe and the USA.
    • Obtaining regulatory approvals internationally for designated product portfolio
    • General regulatory advice to senior team for designated product portfolio
    • Manage national regulatory commitments and submissions
    • Manage orphan drug designations for EU, USA and Australia
    Further Key focus -
    • Update documentation as required in response to Regulatory Agency comments/questions
    • Maintain awareness of regulatory legislation and guidelines in EU, US and other relevant markets
    • Apply for MA, variations and annual update reports in Europe including CH
    • Prepare modules for the e-CTD dossier
    • File substantial amendments as required
    About you -
    • Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline
    • Biological/medical education/knowledge
    • Working knowledge of international regulatory standards in the areas
      of quality, safety and efficacy
    • negotiation skills
    • Excellent attention to detail
    • Ability to plan, organise and follow up with a minimum of supervision
    • Strong willingness to learn
    • Ability to work in a team environment
    • Flexibility to adapt to a small company’s multiple task requirements
    • Effective verbal and written communication in individual and group settings
    • Research skills (ability to source information and to review regulatory legal background)
    If this role sounds like something you'd be interested in discussing further, please reach out to me on will.stewart@randstad.com.au to learn more about the company and role.

    At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

    Randstad has been given the opportunity to support one of our flagship clients in the Pharmaceutical space, who are currently recruiting a key position of Regulatory Affairs Project Manager, to be based in central Melbourne. This role gives you the opportunity for progression within this growing organisation, dealing with national and International teams, based from the client's site here in central Melbourne. Also offering the opportunity to work from home with flexibility and a package of $120-$140k + super depending on experience. The main purpose of the role is to support the International Regulatory Affairs management team across the wider business, with key focus on -
    • Preparation and submission of marketing authorization applications in International markets, including Australasia, Europe and the USA.
    • Obtaining regulatory approvals internationally for designated product portfolio
    • General regulatory advice to senior team for designated product portfolio
    • Manage national regulatory commitments and submissions
    • Manage orphan drug designations for EU, USA and Australia
    Further Key focus -
    • Update documentation as required in response to Regulatory Agency comments/questions
    • Maintain awareness of regulatory legislation and guidelines in EU, US and other relevant markets
    • Apply for MA, variations and annual update reports in Europe including CH
    • Prepare modules for the e-CTD dossier
    • File substantial amendments as required
    About you -
    • Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline
    • Biological/medical education/knowledge
    • Working knowledge of international regulatory standards in the areas
      of quality, safety and efficacy
    • negotiation skills
    • Excellent attention to detail
    • Ability to plan, organise and follow up with a minimum of supervision
    • Strong willingness to learn
    • Ability to work in a team environment
    • Flexibility to adapt to a small company’s multiple task requirements
    • Effective verbal and written communication in individual and group settings
    • Research skills (ability to source information and to review regulatory legal background)
    If this role sounds like something you'd be interested in discussing further, please reach out to me on will.stewart@randstad.com.au to learn more about the company and role.

    At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.