Leading Pharmaceutical and Medical Device Commercialisation in Australia.
With over 100 staff and 23 years of experience, we deliver tailored solutions to clients locally and globally through our expertise and insights within the pharmaceutical, medical device, diagnostic, and consumer healthcare industries.
The Opportunity
This permanent, full-time position reports to the Manager and works within the Regulatory, Quality & Compliance team to deliver a range of product development projects and regulatory applications in Australia, New Zealand, and Japan and Asia Pacific region.
You will act as Project Manager, providing project leadership, including client liaison, project scoping and proposal development, project team resourcing, project management and delivery, and client follow-up.
This role contributes to the BU's business growth efforts by proactively identifying business development opportunities and working with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CE can assist.
Key Responsibilities:
* Foster relationships and collaborate with other business units to support cross-collaboration within the business, drive innovation, create efficiencies, and expand service offerings across the business.
* Provide high-quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.
* Supervise and mentor other members of the project team as required.
* Deliver strategically and technically sound project outcomes, regulatory submissions, reports, and presentations according to agreed deadlines and client requirements.
The Team
Our highly experienced Regulatory, Quality, and Compliance team has in-depth knowledge of the regulatory environment in the region. We assist our clients with the development of effective submission strategies, helping them navigate the complex regulatory environment and various challenges during the development, approval and life-cycle management process.
We have a trusted history of success, managing over 160 projects each year, including the submission of 60 major applications to regulatory authorities.
About You
This role is a fantastic opportunity for an experienced regulatory professional with expertise in the Australian, New Zealand, and/or JAPAC regulatory landscapes. You bring a proven track record in regulatory roles and have a passion for both learning and sharing your knowledge of the pharmaceutical or healthcare industry.
Strong project and people management skills and exceptional communication abilities are key to succeeding in this role.
Desired Qualifications and Experience:
* Completed studies in pharmaceutical sciences or related scientific fields.
* Proven record of consulting experience in Australian and New Zealand and/or JAPAC regulatory affairs, preferably in a commercial environment.
* Comprehensive knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures.
* Experience in technical/medical writing, particularly associated with therapeutic product requirements.
* Experience in the review, critical evaluation, and presentation of clinical, nonclinical, and quality data.
* Proven problem-solving and project management skills.
* Proven experience in people supervision, mentoring, and leadership.
* Post-graduate qualifications in a relevant discipline are preferable.
The Rewards...
* Creative Solutions:Thrive on providing creative solutions to complex problems.
* Diverse Projects:Love being exposed to diverse projects.
* Ambiguity:Feel comfortable with ambiguity and see it as an opportunity to generate insights.
* Flexibility:Work flexibly and adapt quickly to changing priorities.