Regulatory Manager – Senior Regulatory Manager

Precision For Medicine

. Provide regulatory strategy and development guidance throughout clinical trials .

Posted 9/21/2026full-timeRemote • RomaniaSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory strategy and compliance throughout the drug development process, with a strong focus on submissions to Regulatory Authorities and clinical trial methodology. Proven ability to lead projects, manage teams, and effectively communicate regulatory positions and strategies.

Highest-signal resume keywords

Regulatory Strategy DevelopmentIND/CTA SubmissionsClinical Trial MethodologyRegulatory Affairs ExperienceProject Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory SubmissionsRegulatory ComplianceDrug Development ProcessRegulatory MilestonesScientific Advice ProceduresClinical Submission LeadershipRegulatory DocumentationICH GCP GuidanceRegulatory Intelligence ToolsFinancial Management

Soft Skills

Effective CommunicationTeam CollaborationProblem SolvingIndependent PlanningRecord-Keeping

Tools & Technologies

Project TrackersRegulatory Intelligence Tools

Industry Keywords

Regulatory AffairsPharmaceutical IndustryCRO ExperienceEU RegulationsUS RegulationsOrphan DesignationsPaediatric PlanningClinical TrialsPost-Approval SubmissionsQuality Initiatives

About the role

Key responsibilities & impact

Provide regulatory strategy and development guidance throughout clinical trials
Guide regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
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
Develop and/or review submission documents to ensure 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 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; 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 trial 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 to meet deadlines
Ability to collect data of consistently high standard
Effective verbal and written communication in English
Proficiency conducting formal presentations to colleagues, investigative staff, and clients

Benefits

Comp & perks

The posting states that employees feel appreciated for their contributions
Employee ideas are valued and nurtured, with opportunities to impact positive change
Equal Opportunity Employer
Reasonable accommodation available for applicants with disabilities