Regulatory Manager – Senior Regulatory Manager

Precision For Medicine

. Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures .

Posted 9/21/2026full-timeRemote • SlovakiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and development for clinical trials, ensuring compliance with applicable regulations and high-quality submissions. Proficient in leading regulatory affairs projects and guiding teams through the drug development process while maintaining knowledge of relevant laws and guidelines.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory Affairs LeadershipKnowledge of ICH GCPRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsCTA/IND ApplicationsRegulatory Document PreparationClinical Trials MethodologyRegulatory Milestones KnowledgePharmaceutical Development RegulationsProject ManagementRegulatory Intelligence ToolsData Collection StandardsFinancial Management Understanding

Soft Skills

Interpersonal SkillsTeam CollaborationProblem-SolvingFlexibilityEffective Communication

Tools & Technologies

Regulatory Tracking SystemsProject TrackersQuality Management Systems

Industry Keywords

CRO ExperiencePharmaceutical IndustryOrphan DesignationsPaediatric PlanningRegulatory Authority Meetings

About the role

Key responsibilities & impact

Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
Ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations
Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
Provide regulatory guidance throughout the clinical development life cycle
Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
Provide strategic regulatory input as required
Develop and/or review submission documents for Regulatory Authorities and Ethics Committees
Represent Global Regulatory Affairs at project team meetings with external and internal customers
Work within project teams and lead regional or global projects when necessary
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
Assist in developing Regulatory Affairs Specialists and other operational staff
Provide input into regulatory strategy and timeline development for new study opportunities
Assist in establishing company standards for high-quality submitted information
Participate in corporate quality initiatives across Clinical Solutions business units
Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
Provide ICH GCP guidance, advice, and training to internal and external clients
Represent Global Regulatory Affairs at business development meetings

Requirements

What you’ll need

Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline
5 years of regulatory experience required for the Manager level
7 years of regulatory experience required for the Senior Manager Regulatory level
Informed knowledge of all aspects of the drug development process, including regulatory milestones
Specialized knowledge of regulatory activities for at least one major region (EU or US)
Experience working in regulatory affairs for a CRO or within the Pharmaceutical Industry
Experience leading Clinical Submissions
Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy
Knowledge of clinical trials methodology, including working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel, including overnight stays
Strong interpersonal skills and ability to contribute to a team environment
Understanding of financial management
Ability to manage multiple varied tasks in a fast-moving environment
Good record-keeping skills
Ability to work and plan independently and in a team environment
Ability to motivate project team members to meet timelines and project goals
Flexible attitude toward work assignments and new learning
Ability to resolve project-related problems and prioritize workload with little management support
Focus on continuous improvement and process efficiency
Ability to collect consistently high-standard data
Effective verbal and written English communication skills
Ability to conduct formal presentations proficiently to colleagues, investigative staff, and clients

Benefits

Comp & perks

Employees feel appreciated for their contributions
Employee ideas are valued and nurtured
Equal Opportunity Employer
Reasonable accommodation available for applicants with disabilities