Regulatory Operations Specialist

1 week ago

Brisbane, Queensland, Australia beBeeRegulatory Full time $120,000 - $150,000
">Regulatory Start Up Manager Role">

About the Job

">

We are seeking an experienced Regulatory Start Up Manager to join our team. This role involves developing and implementing a regulatory start up strategy for assigned projects, ensuring compliance with relevant regulations.

">

Key Responsibilities

">
  • ">
  • Define a comprehensive Regulatory Start Up (RSU) strategy and prepare an RSU management plan;">
  • Oversee the execution of regulatory start up for assigned projects in accordance with the RSU strategy;">
  • Collaborate with local regulatory start up teams to deliver agreed project scope in compliance with the RSU management plan;">
  • Distribute start up related documents to local regulatory start up teams;">
  • Oversee customization of core start-up documents to local requirements;">
  • Ensure preparation and distribution of core contract and budget templates to applicable team members;">
  • Oversee submission processes to health authorities, ethics committees, and other review bodies; provide regional coordination for meeting approval timelines;">
  • Proactively identify risks to start up and escalate to the Project Manager;">
  • Provide timely updates on regulatory start up progress to the Project Manager;">
  • Present at external and internal meetings including project kick-off and other meetings.">
">

Requirements

">
  • ">
  • Graduate in a clinical, pharmacy, or life sciences related field;">
  • Experience managing start up in more than one country and/or region;">
  • At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations;">
  • Thorough knowledge of applicable regulations;">
  • Able to manage in a matrix environment;">
  • Confident decision-making and problem-solving;">
  • Strong presentation, documentation, and people skills;">
  • High proficiency in English.">
">

Benefits

">
  • ">
  • Flexible working options;">
  • Parental leave for both parents;">
  • Flexible leave entitlements;">
  • Wellness programs;">
  • Ongoing development programs.">
">

About Us

">

We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

">

  • Regulatory Operations Specialist

    1 week ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $120,000 - $160,000

    Job Description:">We are seeking a skilled Regulatory Start Up Manager to oversee the execution of regulatory start-up for assigned projects. Key responsibilities include defining a RSU strategy, preparing a RSU management plan, and collaborating with local regulatory start-up teams.">Required Skills and Qualifications:">A graduate degree in a clinical,...

  • Regulatory Specialist

    3 days ago

    Brisbane, Queensland, Australia Powerlink Full time

    **At Powerlink, every possibility starts with you**:We believe life's about possibilities. And so is the future. That's why we need you.We're working at the heart of Queensland's energy transformation. Now more than ever, we need people who want to help us deliver a world-class energy future and ensure we continue to navigate through this once in a...

  • Regulatory Specialist

    1 week ago

    Brisbane, Queensland, Australia Australian Retirement Trust Full time

    **Take hold of a monster opportunity in our Transformation Management Office as a Regulatory Specialist. If you're a good fit for this role and live in Brisbane or Sydney, we'd love you to apply.****Why join us?**- You'll get 14% super as standard, to help your future come alive.- Unleash your potential and build a career to be proud of through excellent...

  • Regulatory Compliance Specialist

    5 days ago

    Brisbane, Queensland, Australia beBeeregulatory Full time $103,000 - $144,999

    Job Title: Regulatory Compliance SpecialistThe role of a Regulatory Compliance Specialist is crucial in ensuring that early childhood education and care services meet the necessary standards and guidelines.

  • Regulatory Compliance Specialist

    1 week ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $93,450 - $101,500

    Job Title:Regulatory Compliance SpecialistAbout the Role:The Regulatory Compliance Specialist will support the Legal/Regulatory Department in maintaining a solid understanding of our organization's mission, vision, and values. This role upholds the standards of our organization and has shared responsibility for assisting with legal, regulatory, and...

  • Regulatory Compliance Specialist

    1 week ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $80,000 - $120,000

    Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Brisbane. As a trusted advisor, you will support the company's compliance function and direct and coordinate regulatory updates in the APAC region.Main Responsibilities:Be a trusted adviser and support the compliance function in BrisbaneLead...

  • Regulatory Compliance Specialist

    7 days ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $96,167 - $115,946

    Regulatory Compliance SpecialistThe Fire Services Act 1990 and Building Fire Safety Regulation 2008 necessitate strict enforcement by a designated unit.As a Regulatory Compliance Specialist, you will collaborate with regional staff to ensure compliance with the aforementioned regulations, prosecution of offenders, and court injunctions for unsafe...

  • Regulatory Compliance Specialist

    7 days ago

    Brisbane, Queensland, Australia beBeeCompliance Full time $90,000 - $120,000

    About This Role:A dynamic and experienced legal professional is sought to join our team as a specialist in regulatory compliance.This role will be instrumental in driving strategic initiatives that support business growth and operational excellence. Key responsibilities include reviewing and advising on legal risks associated with contracts and commercial...

  • Regulatory Compliance Specialist

    7 days ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $81,432 - $108,332

    Job Title: Regulatory Compliance SpecialistThe Regulatory Compliance Specialist plays a critical role in supporting policy initiatives relevant to medicines within the Medicines Approvals and Regulation Unit. This involves preparing briefing documents, work instructions, fact sheets, guidance documents, submissions, correspondence, and reports.About this...

  • Regulatory Start Up Specialist

    2 weeks ago

    Brisbane, Queensland, Australia beBeeRegulatory Full time $100,000 - $150,000

    Regulatory Start Up SpecialistThis position offers an exciting opportunity to work with our team as a Regulatory Start Up Specialist. In this role, you will be responsible for defining and implementing regulatory start up strategies for assigned projects.