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May

Regulatory Operations Associate

Novotech - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

About Novotech

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.

Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.

Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary carers, and regular training, learning, and international knowledge-sharing opportunities.

About The Opportunity

Newly created role due to business growth and expansion across Asia Pacific. As a member of our Regulatory Operations team you will be supporting submissions for project teams in primarily in Australia and New Zealand, but also across the Asia region. Ensuring ICH GCP and Regulatory compliance is fundamental to the conduct of clinical research, you will be working as part of a collaborative team with a strong focus on key deliverables.

Responsibilities

Reporting to the Regulation Operation Team Lead, your key responsibilities include but are not limited to:

  • Planning, preparation, review and provision of high quality Ethics Committee and Health Authority submissions to project teams, to ensure timely clinical trial approval.
  • Preparation, review and submission of Health Authority applications on behalf of the clinical trial sponsor.
  • Review and approval of proposed packaging and labelling for clinical trial material.
  • Customisation and review of Patient Information Sheet/Consent form (PISCF). Review and approval of proposed packaging and labelling for clinical trial material.
  • Keep abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
  • Represent Regulatory Operations Group (ROG) at client and project team meetings, providing input to timelines and study plans.
  • Develop and maintain tracking tools to ensure status of work and progress towards timelines is clearly documented and available to project teams.
  • Keep abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.


Required Qualification & Experience
  • Graduate in a clinical, pharmacy or life sciences related field.
  • At least 2 years clinical research experience gained in a pharmaceutical company or CRO.
  • Must have experience in HREC submission and PISCF.
  • Good knowledge on start-up process is preferred.

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is committed to offering Equal Employment Opportunities (EEO) where everyone has equal access to employment opportunities based on merit, without fear of discrimination or harassment.

Melbourne, VIC

Health, Medical & Pharmaceutical




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