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 • HungarySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and compliance throughout the clinical development life cycle, with a strong focus on submission documents and regulatory authority interactions. Possesses specialized knowledge of drug development processes and the ability to lead and motivate project teams effectively.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial MethodologySubmission Document PreparationRegulatory Affairs ExperienceICH GCP Guidance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationCTA/IND Application CompilationRegulatory ComplianceClinical Submission LeadershipRegulatory Milestone KnowledgeDrug Development Process UnderstandingRegulatory Intelligence ToolsProject ManagementFinancial ManagementClinical Study Result Interpretation

Soft Skills

Interpersonal SkillsTeam CollaborationProblem-SolvingEffective CommunicationMotivational Leadership

Tools & Technologies

Regulatory Intelligence ToolsProject TrackersSubmission Management Systems

Industry Keywords

Regulatory AffairsPharmaceutical IndustryCRO ExperienceOrphan DesignationsPaediatric PlanningAccelerated ProceduresRegulatory Authority MeetingsClinical Development Life CycleICH GuidelinesGCP Compliance

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
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 and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
Develop and review submission documents to ensure compliance with regulatory standards
Represent Global Regulatory Affairs at internal and external project team meetings
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
Contribute to 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 level
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)
Regulatory affairs experience working 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 trial methodology, including protocols and indications
Knowledge and expertise with 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 and 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 goals
Ability to resolve project-related problems and prioritize workload
Effective verbal and written English communication skills
Proficiency in formal presentations to colleagues, investigative staff, and clients

Benefits

Comp & perks

Remote work arrangement in Hungary
Regular full-time employment
Opportunities to work with a growing global team
Employee contributions and ideas valued and nurtured
Reasonable accommodation available for applicants with disabilities