Regulatory Manager / Senior Regulatory Manager (Oncology)

Location: Remote, Slovakia; availability for domestic and international travel, including overnight stays, is required.

Company

Precision for Medicine is a contract research organization integrating clinical trial execution, scientific expertise, laboratory capabilities, and data sciences to support the development of life-changing therapies, with a focus on oncology and rare disease.

What you will do

• Provide regulatory strategy and development guidance throughout the clinical development life cycle.
• Compile, coordinate, and review submissions to Regulatory Authorities and Ethics Committees, including CTA/IND applications, amendments, annual reports, and marketing applications.
• Support scientific advice and regulatory authority meetings, orphan designations, paediatric planning, and accelerated procedures.
• Represent Global Regulatory Affairs in internal, client, project, and business development meetings.
• Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans, trackers, regulatory intelligence tools, quality initiatives, and regulatory standards.

Requirements

• Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
• At least 5 years of regulatory experience for the Manager level or 7 years for the Senior Manager level.
• Regulatory affairs experience in a CRO or pharmaceutical industry, including experience leading clinical submissions.
• Knowledge of drug development, clinical trial methodology, regulatory milestones, and relevant pharmaceutical regulations and guidance.
• Specialized regulatory experience in at least one major region, including the EU or US, and knowledge of INDs, CTAs, amendments, scientific advice procedures, and post-approval submissions.
• Professional English communication skills are required.

Culture & Benefits

• Remote work within Slovakia as part of a growing global organization.
• Collaboration with internal teams, external clients, investigative staff, and regulatory authorities.
• Opportunities to contribute to oncology and rare disease programs.
• Responsibilities include mentoring Regulatory Affairs Specialists and supporting continuous improvement.