Regulatory Affairs Specialist
hace 3 días
About Precision Medicine Group
Precision Medicine Group is a pioneering company in the life sciences industry, revolutionizing the way clinical trials are conducted. With a strong focus on Oncology and Rare Disease, we integrate cutting-edge technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing life-changing therapies to patients.
We're seeking a highly skilled Regulatory Affairs Specialist to join our team, based in various countries including the UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.
Job Summary
This is an exciting opportunity to provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. As a Regulatory Affairs Specialist, you will ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
Key Responsibilities:
- Provide regulatory guidance throughout the clinical development life cycle
- Compile, coordinate, and review applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
- Develop and/or review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
- Serve as a representative of Global Regulatory Affairs at project team meetings with both external and internal customers
- Work within a project team, leading projects for the region or globally, as needed
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
- Maintenance of project plans, project trackers, and regulatory intelligence tools related to assigned responsibilities
- Assist in the development of Regulatory Affairs Specialists and other operational area staff, as required
- Provide input into regulatory strategy and timeline development for new study opportunities
- Assist in establishing company standards to ensure the highest quality of submitted information
- Participate in maintaining and executing corporate quality initiatives across business units within clinical solutions
- Stay up-to-date with laws, regulations, and guidelines governing drug development and approval
Qualifications
To be successful in this role, you'll need:
- Bachelor's degree or equivalent experience in a scientific or healthcare discipline
- Minimum 5 years of Regulatory experience, preferably with a Clinical Research Organisation
- Computer literacy (MS Office/Office 365)
- Fluent in English
Salary Range: $90,000 - $120,000 per annum, depending on location and experience. We offer a competitive benefits package, including health insurance, retirement plan, and generous paid time off.
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