Regulatory Affairs Specialist

1 week ago

Macquarie Park, Australia Icon Plc Full time

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to
be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Primary Responsibilities
- Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
- Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
- Maintain a strong customer service management approach with clients.
- Lead project teams and advise departments on regulatory standards issues and strategies
- Develop, write, and implement standards and procedures related to regulatory operations.
- Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
- Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
- Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
- Completing other appropriate duties as assigned by line manager that require similar skills

You will need:

- Experience in eCTD, NeeS, Paper Submissions.
- Experience in EU, US and Canada HA submissions.
- Experience in Lorenz Docubridge and ISI Tool Box
- Experience in sequence building and document level publishing
- Good knowledge on the CTD sections.

Benefits of Working at ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

**Job Types**: Full-time, Permanent

Pay: $70,000.00 - $85,000.00 per year

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Macquarie Park, NSW 2113: Reliably commute or planning to relocate before starting work (preferred)

Work Authorisation:

- Australia (preferred)

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