Global Start-Up Expert

4 days ago

Melbourne, Victoria, Australia beBeeregulatory Full time $100,000 - $115,000
Regulatory Submissions Specialist

We are currently seeking a Regulatory Submissions Specialist to join our Clinical Operations team in Melbourne, Australia.

About the Role

This is an exciting opportunity for a highly skilled and motivated individual to manage and execute all aspects of global start-up. The successful candidate will perform quality checks on submission documents and site essential documents, prepare and approve informed consent forms, review pertinent regulations to develop proactive solutions to start-up issues and challenges, and present during bid defenses, general capabilities meetings, and audits.

The ideal candidate will have more than 5 years of experience in clinical research, preferably with a CRO, with experience including CRA or project management. Regional experience will be highly advantageous. Strong oral and written communication skills are essential.

Key Responsibilities:
  • Evaluate and manage submission documents and site essential documents.
  • Develop and implement processes to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure smooth execution of start-up activities.
  • Provide guidance and support to colleagues on regulatory matters.
Benefits

We offer a competitive compensation and benefits package, flexible work environment, structured career paths with opportunities for professional growth, company-sponsored employee appreciation events, and employee health and wellness initiatives.

About Us

Our organization is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective.

  • Global Start-Up Lead

    1 day ago

    Melbourne, Victoria, Australia beBeeManager Full time $100,000 - $115,000

    Regulatory Submissions Manager RoleWe are seeking an experienced Regulatory Submissions Manager to manage and execute all aspects of global start-up, perform quality checks on submission documents, prepare and approve informed consent forms, review pertinent regulations, and present during bid defenses and audits.Key Responsibilities:Efficiently manage and...

  • Start-Up & Acquisition Operations Lead

    5 days ago

    Melbourne, Victoria, Australia Aspire Early Education & Kindergarten Full time

    Join to apply for the Start-Up & Acquisition Operations Lead role at Aspire Early Education & Kindergarten1 day ago Be among the first 25 applicantsJoin to apply for the Start-Up & Acquisition Operations Lead role at Aspire Early Education & KindergartenConnect, Learn & Grow with Aspire Aspire Early Education & Kindergarten is a proudly Australian-owned...

  • Global Mobility Expert

    18 hours ago

    Melbourne, Victoria, Australia beBeeMobility Full time $100,000 - $145,000

    Expert Career GuidanceWe provide unparalleled support for professionals seeking global opportunities.The OpportunityOur team is part of a worldwide network of offices, delivering expert guidance on international assignments and optimizing program design.Your Key ResponsibilitiesCollaborate closely with clients to understand their needs and deliver...

  • Global Transfer Pricing Expert

    5 days ago

    Melbourne, Victoria, Australia beBeeTransferPricing Full time $150,000 - $200,000

    Senior Consultant OpportunityThis is a fantastic opportunity for an experienced Senior Consultant who is ready to take their career to the next level and grow professionally. Our Global Transfer Pricing team provides expert advice to clients on transfer pricing matters, helping them to manage their global operations effectively.Key Responsibilities:Develop...

  • Global Implementation Expert

    1 day ago

    Melbourne, Victoria, Australia beBeeImplementation Full time $130,000 - $160,000

    Job TitleWe are seeking a highly skilled Global Implementation Consultant to join our team. As a key member of our implementation team, you will be responsible for delivering exceptional client service and implementing solutions that meet their business needs.Key ResponsibilitiesDevelop and implement client solutions using industry best practices and the ADP...

  • Global Sourcing Expert

    3 days ago

    Melbourne, Victoria, Australia beBeeSourcing Full time $80,000 - $110,000

    Job Title: Global Sourcing ExpertWe are seeking a skilled professional to join our team as a Global Sourcing Expert. This is an exciting opportunity for someone who is passionate about sourcing and procurement, and has a strong understanding of global markets and cultures.The ideal candidate will have experience in sourcing and procuring products, materials,...

  • Commissioning Expert

    10 hours ago

    Melbourne, Victoria, Australia beBeeMechanical Full time $90,000 - $120,000

    Job Title:Mechanical Commissioning SpecialistJob DescriptionThis role involves working as part of a team responsible for the commissioning of mission-critical mechanical equipment, start-up and testing, as well as developing maintenance programs and plans.Building commissioning professionals develop and execute the commissioning tests to demonstrate to the...

  • Global Logistics Expert

    18 hours ago

    Melbourne, Victoria, Australia beBeeLogistics Full time $96,100 - $134,500

    As a global logistics expert, you play a crucial role in ensuring the efficient management of shipments worldwide.Your primary objective is to deliver exceptional service excellence by specializing in international shipping and providing peace of mind for clients through swift and reliable delivery to any destination.To achieve this, you will leverage your...

  • Global Mobility Expert

    2 days ago

    Melbourne, Victoria, Australia beBeeTax Full time $120,000 - $160,000

    Global Mobility Services ExpertJob SummaryWe are seeking a talented individual to join our high-performing advisory team as a Senior Consultant.The successful candidate will work across all areas of global mobility and related tax matters, providing a value-add advisory service to a diverse client portfolio.Key Responsibilities:Deliver consulting services in...

  • Global Workforce Expert

    3 days ago

    Melbourne, Victoria, Australia beBeeMobility Full time $90,000 - $125,000

    We're shaping the future of global workforce management.The OpportunityOur team is part of an international network of offices operating on a global basis. We help clients harness the right people with the right capabilities in the right place at the right cost.Talent mobility experts will move professionals across the globe and reshape the way businesses...