Regulatory Affairs Associate

Basic qualifications:

A degree in pharmacy, chemistry or pharmacology with a preference for post graduate studies.

Preferred qualifications:

Post graduate qualification

Details:

  • Supportive and high achieving team
  • Genuine career progression opportunities
  • Global approach

GlaxoSmithKline (GSK) is an innovative global leader in pharmaceutical research and development with a long and proud history in Australia. We are a patient focused organisation with a mission to improve the quality of human life, enabling people to do more, feel better and live longer. Our diverse business is made up of three areas: Pharmaceuticals, Consumer Healthcare and Vaccines.

As part of our highly engaged and high achieving Regulatory Affairs team you will primarily be responsible for supporting the preparation, submission and tracking of accurate and timely regulatory applications for prescription medicines and vaccines. Reporting into the Regulatory Affairs Manager this is a varied role that will see you engaging with a broad range of external and internal stakeholders.

Your responsibilities will be broad and will also include:

  • Responsibility for the maintenance of registered products ensuring product compliance.
  • Working closely with local brand teams and global groups to proactively manage responses to questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe.
  • Providing input and expertise to assist commercial, technical and marketing teams with new product initiatives and activities.

To be successful in this role you will have:

  • A science based degree.
  • First-hand experience with regulatory submissions in Australia and New Zealand.
  • Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry preferably in the area of prescription medicines.
  • Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders.
  • Strong analytical skills, excellent attention to detail and a commitment for compliance processes.

This role represents a great opportunity to work in an innovative global pharmaceutical company within a close-knit and engaged team working on a large pipeline of prescription products. GSK is committed to developing its people and providing on the job training and opportunities.

Contact information:

You may apply for this position online by selecting the Apply now button.

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