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 • PolandSenior💰 PLN 190,200 - PLN 285,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and development for clinical trials, ensuring compliance with regulatory standards and effective communication with regulatory authorities. Capable of leading project teams and managing submissions while maintaining high-quality standards across the clinical development life cycle.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory Affairs ExperienceICH GCP GuidanceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIND/CTA ApplicationsRegulatory ComplianceClinical Trials MethodologyRegulatory MilestonesScientific Advice ProceduresDrug Development ProcessRegulatory IntelligenceSubmission Document DevelopmentOrphan Designations

Soft Skills

Interpersonal SkillsTeam CollaborationProblem SolvingEffective CommunicationMotivational Leadership

Tools & Technologies

Regulatory Intelligence ToolsProject Tracking SoftwareDocument Management Systems

Industry Keywords

Pharmaceutical IndustryCRO ExperienceRegulatory AuthoritiesClinical Development Life CyclePaediatric Planning

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 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 documents, and marketing applications
Provide strategic regulatory input as required
Develop and review submission documents to ensure compliance with regulatory standards
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, 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
Maintain and execute 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 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), including submissions to Regulatory Authorities, 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 and interpret clinical and pre-clinical study results for regulatory positions and strategy
Knowledge of clinical trials methodology, 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 and maintain good records
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 with little management support
Ability to communicate effectively in English, verbally and in writing
Proficiency conducting formal presentations to colleagues, investigative staff, and clients

Benefits

Comp & perks

Discretionary annual bonus
Private medical insurance
MultiSport Card
Life insurance
Pension
Home working allowance
Vacation
Other benefits
Reasonable accommodation for applicants with disabilities