Senior Regulatory Affairs Manager

Posted 5 September

Part or Full time  ·   Clinical Drug Development    ·    Biotech

The company

Our client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms.  Now is an exciting time, as they move to a brand-new facility in Notting Hill.

The role

Reporting to the Head, Quality Assurance, your key remit will be to oversee all regulatory affairs functions for the company. You will support the clinical implementation of strategies and procedures that ensure ongoing compliance with government regulations that will lead to successful registration of our clients’ products.

  • Develop and implement regulatory strategies to support clinical development and product registration.
  • Advise on regulatory pathways and strategies for INDs and product registration submissions.
  • Preparation and maintenance of Technical Product files.
  • Liaising with internal stakeholders and contract manufacturing organisations regarding product information and details to collate dossiers for product registration.
  • Compiled dossiers to include Manufacturing data, Physical & Chemical properties, Biocompatibility and Clinical data, Quality plans, Risk analysis, ISO product testing and the Essential Requirements checklist.
  • Preparation and submission of registration documents to applicable regulatory agencies
  • Liaising and managing communication with FDA, TGA and other regulatory agencies.

Expertise required

  • Tertiary qualifications in biological/life sciences or bachelor’s degree in science or pharmacy.
  • 5+ years’ experience working in regulatory affairs for the pharmaceutical industry or a regulatory agency.
  • Demonstrated working knowledge of drug and/or device registration processes and technical dossiers.
  • Key regulatory documents such as NDAs, INDs, briefing documents, Investigator Brochures.
  • Knowledge of current literature and the regulatory guidelines for nonclinical drug development within Australia. Additional countries an advantage.
  • Demonstrated ability to collaborate with internal stakeholders and external consultants to drive and manage compliance with international regulatory agencies including the TGA. Experience with the FDA an advantage.
  • Demonstrated ability to work both independently and as part of a multidisciplinary research team, including an ability to work on multiple projects simultaneously alongside clinical, R&D, QA, supply chain, manufacturing, and management personnel.

Desirable

  • Experience in Class I and II regulated medical devices.
  • Exposure to clinical development with respect to pharmaceutical products and/or medical devices.
  • Experience with CMC of a pharmaceutical product.

The application

Our client offers flexibility, and the opportunity to work full or part time. This role is at the frontline of the development of new innovative technologies and  is moving to a brand-new state of the art facility in Notting Hill.

To join our client in this exciting opportunity, please email your cover letter & CV to careers@mexec.com. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC

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