Senior Consultant - Regulatory, Quality & Compliance

Details of the offer

Benefits: Work from anywhere in AustraliaOpportunity to mentor and develop junior staffExposure to diverse projects across pharma and biotech About the company:
A leading consultancy firm specializing in regulatory affairs, quality, and compliance for the healthcare and life sciences industries.

About the opportunity:
Join our client's dynamic Regulatory, Quality & Compliance team as a Senior Consultant, managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.
This role offers the chance to work on diverse projects, from large global pharma to small biotech's.

Duties: Manage multiple client projects simultaneouslyDevelop regulatory strategies and pathway optionsPrepare and review regulatory submissions, including literature-based applicationsLiaise with clients and regulatory authoritiesMentor junior team membersContribute to business development initiativesProvide expert advice on regulatory affairs and complianceAssist in responding to regulatory agency questionsSupport product lifecycle management activities Skills and Experience: Degree in Science/Pharmacy or related disciplineMinimum 8 years' experience in Australian/global regulatory affairs (Rx and biologicals preferred)Strong knowledge of TGA/Medsafe regulations and guidelinesExperience in clinical data evaluation and presentation of clinical and non-clinical dataConfidence in handling challenges and finding solutionsCommercial acumen and understanding of the broader healthcare environment Culture:
Our client fosters a supportive and friendly environment where people genuinely care about each other.
Our client values work-life balance and offers a close-knit culture with hands-on support for new team members.
Join them to be part of a high-performing team that celebrates collective success.

How to Apply:
Click apply or contact Erin Cox at ****** or Jo Turner at ****** for a confidential discussion.
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Nominal Salary: To be agreed

Job Function:

Requirements

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