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Senior Regulatory Affairs Specialist
5 months ago
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.
We are looking for a Senior Regulatory Affairs Specialist who has the ability to work independently for routine activities and submissions in Australia and New Zealand.
**Responsibilities**:
- Preparation, compilation and submission of routine Regulatory submissions e.g. CTN/CTA, Variations / lifecycle submissions, orphan designation or priority review.
- Contribute to more complex projects (early development, MAA, Post Marketing) contributing to (for example) review and compilation of documents for regulatory, document product label review, translation requirements, fee requirements and payments, submission planning.
- Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within SRS.
- Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required.
- Undertake all required tasks requested to meet departmental and project goals, as appropriate.
- Participate in regulatory and/or clinical trial project teams as required.
- Responsible for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders.
- Identify department process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department's goals.
- Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions (as necessary under supervision).
- Assist in review or update of existing department standard operating procedures.
- Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary.
- Maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems.
You Will Need:
- A minimum of a Bachelor's degree or local equivalent.
- Minimum of 2 - 4 years in Regulatory Affairs in the Pharmaceutical industry.
- Ability to multi-task, & support various projects.
- Be able to solve problems in pro-active and timely manner.
Highly regarded:
- TGA and/or Medsafe experience.
- Experience in both clinical regulatory and CMC regulatory advantageous.
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.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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