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 • SerbiaSeniorWebsite

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 stakeholders. Proficient in managing submissions to regulatory authorities and leading project teams in a fast-paced environment.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory ComplianceICH GCP GuidanceTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsIND/CTA SubmissionsRegulatory MilestonesClinical Trials MethodologyRegulatory DocumentationScientific Advice ProceduresDrug Development ProcessRegulatory Intelligence ToolsProject ManagementFinancial Management

Soft Skills

Interpersonal SkillsEffective CommunicationProblem-SolvingTeam CollaborationIndependent Planning

Tools & Technologies

Regulatory Tracking SystemsProject TrackersSubmission Management Tools

Industry Keywords

Pharmaceutical IndustryCRO ExperienceEU RegulationsUS RegulationsOrphan DesignationsPaediatric PlanningAccelerated Procedures

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
Provide strategic regulatory input as required
Develop and/or 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, project trackers, and regulatory intelligence tools; update Regulatory Leadership
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 and 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)
Experience with submissions to Regulatory Authorities, including INDs/CTAs, 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 and team-environment skills
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 resolve project-related problems and prioritize workload with little management support
Effective verbal and written communication in English
Ability to conduct formal presentations proficiently to colleagues, investigative staff, and clients

Benefits

Comp & perks

Regular full-time employment
Remote work arrangement
Opportunity to join a growing global team
Employee contributions valued and nurtured
Opportunity to impact positive change for the company