Global Start-Up & Regulatory Affairs Lead
- Experience Level
- Experienced (non-manager)
Due to our ongoing global expansion, PRA are hiring a Global Start Up & Regulatory Affairs Lead to join our growing Global Regulatory Clinical Services team in APAC. This is a sponsor facing position focusing on start-up activities. 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 APAC with flexibility to be home or office based.
- You will take ownership of managing 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 you knowledge and become an expert on regions outside of your own
- Responsible for the ensuring efficient start-up process on assigned studies, focusing on all EC and IRB submissions and acting as main contact with authorities
- 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
- Joining a team of 8, 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 to many countries across APAC, there is also flexibility to be home of office based in this role depending on your preference
- 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 a talented communicator who enjoys relationship building, managing sponsor interaction and taking a lead on projects
- Previous clinical trials Start Up experience and a strong knowledge of current ICH 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 desired
- Previous experience working within CRO is required
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 Opportunity Employer. We welcome and encourage diversity in the workplace.
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