Regulatory Submission Specialist

7 days ago

Sydney, New South Wales, Australia PSI CRO Full time $60,000 - $80,000 per year

Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

We're looking for a Regulatory Specialist on a 18-month contract to cover maternity leave. This is a great opportunity for someone looking to gain hands-on experience in clinical research.

Office-based in Macquarie Park, Sydney

Your role:

  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications.
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters.
  • Review translations of essential documents subject to clinical trial submission.
  • Track the regulatory project documentation flow.
  • Review documents to greenlight IP release to sites.
  • Manage safety reporting to authorities.
  • Deliver regulatory training to project teams.
  • Assist with feasibility research and business development requests.

  • Regulatory Submission Specialist

    7 days ago

    Sydney, New South Wales, Australia PSI CRO AG Full time $90,000 - $120,000 per year

    Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Regulatory Submission Specialist

    4 days ago

    Sydney, New South Wales, Australia Psi Cro Full time

    **Company Description**We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Regulatory Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $17,000 - $25,000

    Job Title: Regulatory Specialist\Thermo Fisher Scientific is seeking a highly skilled and experienced Regulatory Specialist to join our team. In this role, you will be responsible for managing the preparation, review, and coordination of Country Submissions in line with global submission strategy.\The successful candidate will have a strong background in...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to deliver regulatory submissions and maintain compliance.Deliver regulatory submissions on time;Ensure accurate company databases and systems by drafting, updating, reviewing and verifying entries;Maintain compliance with regulations and provide expert advice as...

  • Regulatory Compliance Specialist

    4 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time

    Job Title: Regulatory Compliance SpecialistAbout the Role:The Regulatory Compliance Specialist plays a vital role in ensuring the company's products meet regulatory requirements and are compliant with post-market regulations. This role is responsible for coordinating regulatory responses to post-market events, preparing and managing submissions, and...

  • Regulatory Support Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Regulatory Support SpecialistThe Regulatory Support Specialist is responsible for providing regulatory support to international country and/or cluster teams.Supports various regulatory activities, including:M1 dossier components (local document authoring and/or coordination)Simple local-only HA query responsesProviding support for cross-functional activities...

  • Country Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

    Country Regulatory Affairs SpecialistA key role in our organization is the Country Regulatory Affairs Specialist, who plays a critical part in ensuring that clinical trials are managed efficiently and effectively.The primary responsibilities of this position involve preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional...

  • Senior Specialist Regulatory Affairs

    1 week ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR\_043232**About ResMed**The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including...

  • Senior Specialist Regulatory Affairs

    1 week ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR/_043232**About ResMed**The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including...