Regulatory Manager / Senior Regulatory Manager

Precision Medicine Group

. 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 submissions to Regulatory Authorities and the drug development process. Capable of leading teams and projects while maintaining high standards for regulatory documentation and communication.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory ComplianceICH GCP GuidanceRegulatory Affairs Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsCTA/IND ApplicationsRegulatory Document PreparationDrug Development ProcessClinical Trials MethodologyRegulatory MilestonesScientific Advice ProceduresPost-Approval SubmissionsRegulatory Intelligence ToolsFinancial Management

Soft Skills

Interpersonal SkillsTeam CollaborationProblem SolvingEffective CommunicationIndependent Planning

Tools & Technologies

Regulatory LeadershipProject PlansTrackers

Industry Keywords

Regulatory AffairsPharmaceutical IndustryCRO ExperienceOrphan DesignationsPaediatric PlanningAccelerated ProceduresRegulatory Authority MeetingsClinical Solutions

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/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
Develop and/or review submission documents for regulatory compliance
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, trackers, and regulatory intelligence tools; update Regulatory Leadership
Assist in developing Regulatory Affairs Specialists and other operational staff
Contribute to regulatory strategy and timeline development for new study opportunities
Help establish company standards for high-quality submitted information
Participate in corporate quality initiatives across Clinical Solutions business units
Maintain 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

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
5 years Regulatory experience required for the Manager level
7 years Regulatory experience required for the Senior Manager Regulatory level
Informed knowledge of all aspects of the drug development process, including regulatory milestones
Specialised knowledge of regulatory activities for at least one major region (EU, US)
Experience with submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
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 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 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 resolve project-related problems and prioritize workload to meet deadlines
Ability to communicate effectively in English, verbally and in writing
Proficiency in formal presentations to colleagues, investigative staff, and clients

Benefits

Comp & perks

Employees feel appreciated for their contributions
Input and ideas valued and nurtured, impacting positive change for the company
Equal Opportunity Employer
Reasonable accommodation available for applicants with disabilities