Global Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
PRA are hiring a Global Regulatory Affairs Associate to join our Global Regulatory Clinical Services team in Australia. Focusing on the start-up phase of clinical trials, you will responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This is role is open to locations across Australia with flexibility to be home or office based.
- You will take ownership of coordinating Regulatory Affairs projects during the start-up of clinical trials globally including the APAC region, EU and Latin America, this will allow you to expand your knowledge and become an expert on regions outside of your own
- You will be the direct point of contact for the sponsor enabling you to foster strong and supportive relationships with clients and provide a consultative approach and practical solutions to any specific issues
- You will gain exposure to a number of therapeutic areas, responsible for the ensuring efficient start-up process on assigned studies, focusing on all EC and IRB submissions and liaising with the relevant authorities
- As a specialist in Regulatory Affairs you will take time to problem solve and investigate specific issues within this niche area and provide consulting services to clients
- Joining a close knit team with good tenure, you will be part of a high-performing culture with access to career development and progression opportunities and be supported by management that encourages internal development
- Location is not a restriction to talent and is open all states across Australia, there is also flexibility to be home or office based depending on your preference and flexible working hours are supported
- The tenure in the management team is incredible, with some joining PRA as IHCRAs and progressing all the way to management positions, these are real and impressive examples of what you can achieve at PRA
- PRA are committed to providing career development pathways to you and provide ongoing support and training to enable you to exceed your career goals
- This role is suited to an ambitious regulatory professional with a minimum of 1 year experience of working across multiple regions, previous CRO experience is required
- Previous clinical trials Start Up experience and a strong knowledge of current ICH GCP and local Regulatory Agency and Ethics Committee regulations and understanding of regional guidelines
- Fluency in spoken and written business English is essential and an additional language is highly desirable
- A team-first and solutions focused approach which fosters positive working relationships with your study team colleagues
PRA is proud to be one of the consistent leaders in the CRO industry globally, employing over 18,000 people across 90 countries. We are committed to the future of clinical development & dedicated to helping our clients improve patient's lives through our partnering with new and innovative pharmaceutical and biotech companies.
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
“PRA Health Sciences is an equal opportunities employer; we welcome and celebrate diversity in the work place and we strive to ensure that all employees feel safe, connected and secure in their working environment”
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