Regulatory Start Up Manager

2 weeks ago

Brisbane, Queensland, Australia Novotech Asia Full time

Minimum Qualifications & Experience:

- Graduate in a clinical, pharmacy or life sciences related field.
- At least 5 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations
- Through knowledge of applicable regulations
- Able to manage in a matrix environment
- Confident decision-making and problem-solving
- Competent working in virtual teams across time zones
- Strong presentation, documentation, and interpersonal skills
- High proficiency in English

**Responsibilities**:

- Define a Regulatory Start-Up (RSU) strategy and prepare a RSU management plan
- Oversee the execution of regulatory start-up for assigned projects in accordance with agreed RSU strategy.
- Ensure collaboration with local regulatory start-up teams to successfully deliver the 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
- Oversee site activation package compilation and approvals
- Proactively identify any risks to start-up and escalate to Project Manager. Develop RSU mitigation plans.
- Provide timely update of regulatory start-up progress to Project Manager
- Present at external and internal meetings including but not limited to: project internal and external meetings, kick-off meetings.
- Serve as a client's contact for regulatory start-up related items
- Support business development by providing relevant information on regulatory start-up and attending Bid Defences to present Novotech's regional capabilities
- Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools,
- Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start-up activities
- Facilitate cooperation between cross-functional teams
- Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence
- Identify areas of inefficiency in regulatory start-up process and make recommendation for improvements.
- Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

  • Regulatory Start Up Manager

    3 weeks ago

    Brisbane, Queensland, Australia Novotech Full time

    OverviewJoin to apply for the Regulatory Start Up Manager role at NovotechBe among the first applicants to apply for this role.ResponsibilitiesDefine a 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...

  • Regulatory Operations Specialist

    2 weeks 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...

  • Regulatory Operations Specialist

    2 weeks 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,...

  • Commissioning Start-Up Supervisor

    2 weeks ago

    Brisbane, Queensland, Australia Arrow Energy Full time

    **About Us**At Arrow, we explore and develop gas fields, produce and sell coal seam gas and generate electricity. We have operations across the Surat and Bowen basins, based in Dalby and Moranbah respectively, as well as our corporate headquarters in Brisbane.Our vision is to be the most competitive and respected developer of unconventional gas value chains...

  • Regulatory Support Officer

    1 week ago

    Brisbane, Queensland, Australia Education Full time

    About the Department of EducationThe Department of Education is dedicated to building an inclusive and diverse workforce that reflects the community and schools we support by treating everyone with respect and dignity. This starts with recruitment and selection. The methods of assessing suitability in the recruitment process may vary. This includes making...

  • Senior Regulatory Programme Manager

    2 weeks ago

    Brisbane, Queensland, Australia beBeeProgram Full time $200,000 - $250,000

    Job OverviewThe ideal candidate will manage the planning and execution of our lead late-stage development program, Atacicept, in alignment with Vera's Regulatory strategy and commitment to health authorities globally.Develop and execute comprehensive regulatory plans, timelines, and budgets for Atacicept while ensuring Regulatory alignment with...

  • Regulatory Specialist

    2 weeks 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...

  • Manager Regulatory Affairs

    1 week ago

    Brisbane, Queensland, Australia Racq Full time

    **Manager Regulatory Affairs****(****Job Number**:**220001MB****)****Description**We are seeking a passionate, experienced regulatory affairs professional for our financial services organisation. As our new Manager Regulatory Affairs, you will coordinate RACQ's external regulatory relations; contributing significantly to the way in which our organisation...

  • Regulatory Breach Reporting

    2 weeks ago

    Brisbane, Queensland, Australia Marsh & Mclennan Companies Full time

    Company:MMC CorporateDescription:We are seeking a talented individual to join our Risk and Compliance team at Marsh McLennan.This role can be based anywhere in Australia.This is a hybrid role that has a requirement of working at least three days a week in the office.Regulatory Breach Reporting and Compliance ManagerAt Marsh McLennan, we're bolstering the...

  • Regulatory Specialist

    1 week 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...