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Precision for Medicine is seeking a Regulatory Manager to join their team. This role is available remotely in Serbia, as well as in the UK, Spain, Hungary, Slovakia, Romania, or Poland.He/she will provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. The Regulatory Manager will ensure the timely preparation of high-quality regulatory submissions in compliance with regulations.Responsibilities:
- Providing regulatory guidance throughout the clinical development life cycle.
- Compiling, coordinating, and reviewing applications to Regulatory Authorities.
- Developing and reviewing documents for submission to Regulatory Authorities and Ethics Committees.
- Serving as a representative of Global Regulatory Affairs at project team meetings.
- Overseeing and coordinating Regulatory Affairs Specialists.
- Maintaining project plans and regulatory intelligence tools.
- Assisting in the development of Regulatory Affairs Specialists.
- Providing input into regulatory strategy and timeline development.
- Assisting in establishing company standards for submitted information.
- Participating in corporate quality initiatives.
- Staying updated on laws, regulations, and guidelines governing drug development.
- Providing ICH GCP guidance and training.
- Serving as a representative of Global Regulatory Affairs at business development meetings.
- Bachelor's degree in a scientific or healthcare discipline.
- 5 years (Manager) or 7 years (Senior Manager) of regulatory experience.
- Computer literacy (MS Office/ Office 365).
- Fluency in English.
- Regulatory affairs experience working for a Clinical Research Organisation.
- Experience leading Clinical Submissions.
- Informed knowledge of drug development and regulatory activities for at least one major region (EU, US).
- Ability to understand clinical and pre-clinical study results.
- Knowledge of clinical trials methodology.
- Knowledge and expertise with relevant regulations and guidance.
- Availability for domestic and international travel.
- Opportunity to work remotely.
- Chance to contribute to groundbreaking cancer therapies research.
- Valued input and ideas with impact on positive change for the company.
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.