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(Senior) Regulatory Manager at Precision Medicine Group

Regulatory Manager role at Precision for Medicine, remote in Slovakia.
Remote
Slovakia
Undisclosed salary

Precision for Medicine is seeking a Regulatory Manager to join their team. This role can be based remotely from the UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland. The Regulatory Manager will provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. They will ensure the timely preparation of high-quality regulatory submissions in compliance with regulations.

The Regulatory Manager will coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.

Role Involves:

  • Providing regulatory guidance throughout the clinical development life cycle.
  • Compiling, coordinating, and reviewing applications to Regulatory Authorities.
  • Developing and/or reviewing documents intended for submission to Regulatory Authorities and/or Ethics Committees.
  • Serving as a representative of Global Regulatory Affairs at project team meetings.
  • Overseeing and coordinating Regulatory Affairs Specialists.
  • Maintaining project plans, project trackers, 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.
  • Keeping abreast of laws, regulations, and guidelines governing drug development and approval.
  • Providing ICH GCP guidance, advice, and training.
  • Serving as a representative of Global Regulatory Affairs at business development meetings.

Requirements:

  • 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 all aspects of the drug development process.
  • Knowledgeable of clinical trials methodology.
  • Knowledge and expertise with relevant regulations and guidance.
  • Availability for domestic and international travel.

Precision for Medicine offers:

  • Opportunity to provide input and have ideas valued.
  • Chance to impact positive change for the company.
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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.