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 • RomaniaSeniorWebsite

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 guidelines. Proficient in leading regulatory submissions and providing strategic input throughout the clinical development life cycle.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory ComplianceICH GCP GuidanceRegulatory Affairs Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ExperienceDrug Development ProcessRegulatory MilestonesClinical Trials MethodologySubmission Document DevelopmentRegulatory Authority MeetingsCTA/IND ApplicationsOrphan DesignationsPaediatric PlanningRegulatory Intelligence Tools

Soft Skills

Effective CommunicationProblem-SolvingTeam CollaborationIndependent PlanningRecord-Keeping

Tools & Technologies

Regulatory Tracking ToolsProject Management Software

Industry Keywords

Regulatory AffairsPharmaceutical IndustryCRO ExperienceClinical DevelopmentRegulatory Guidance

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 and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
Provide strategic regulatory input as required
Develop and review submission documents for 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; 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 current 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
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 working in regulatory affairs 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 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
Employee ideas are valued and nurtured
Equal Opportunity Employer
Reasonable accommodation available during the application process