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 • 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 compliance for clinical trials, including preparation of high-quality submissions and coordination with regulatory authorities. Possesses strong knowledge of drug development processes and the ability to lead projects while managing multiple tasks effectively.

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 ApplicationsScientific Advice ProceduresRegulatory MilestonesClinical Trials MethodologyRegulatory DocumentationDrug Development ProcessRegulatory Intelligence ToolsProject ManagementFinancial Management

Soft Skills

Effective CommunicationProblem-SolvingTeam CollaborationIndependent PlanningRecord-Keeping

Industry Keywords

Pharmaceutical IndustryCRO ExperienceEU RegulationsUS RegulationsOrphan DesignationsPaediatric PlanningRegulatory Authority MeetingsPost-Approval SubmissionsClinical Development Life CycleQuality Initiatives

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
Prepare and coordinate well-organized, high-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 meetings, orphan designations, paediatric planning, and marketing applications
Develop and review submission documents for compliance with regulatory standards
Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
Work within project teams and lead projects for a region or globally 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
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

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 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 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
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
Ability to collect data of consistently high standard
Effective verbal and written communication in English
High 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
Employee appreciation and valued contributions
Reasonable accommodation for applicants with disabilities