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 • United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and development for clinical trials, ensuring compliance with applicable regulations and timely submissions. Possesses strong knowledge of drug development processes and the ability to lead and coordinate regulatory activities across project teams.

Highest-signal resume keywords

Regulatory Strategy DevelopmentClinical Trial SubmissionsRegulatory Affairs ExperienceKnowledge of Drug Development ProcessInterpersonal Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIND/CTA ApplicationsScientific Advice ProceduresRegulatory ComplianceClinical Trials MethodologyRegulatory MilestonesProject ManagementRegulatory Intelligence ToolsQuality AssuranceFinancial Management

Soft Skills

Team CollaborationEffective CommunicationProblem SolvingMotivational LeadershipIndependent Planning

Tools & Technologies

Regulatory LeadershipProject TrackersQuality Initiatives

Industry Keywords

Pharmaceutical IndustryCRO ExperienceEU RegulationsUS RegulationsICH GCP

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
Ensure timely preparation of well-organised, quality regulatory submissions compliant with applicable regulations
Coordinate and prepare regulatory documents for 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 Regulatory Authorities and Ethics Committees
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
Maintain and execute corporate quality initiatives across Clinical Solutions business units
Keep current with 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 and 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 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 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 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 for applicants with disabilities
Privacy and data protection support for applicants