Regulatory Manager – Senior Regulatory Manager

Precision For Medicine

Regulatory Manager overseeing regulatory strategy for clinical trials at Precision for Medicine. Collaborating with global teams to ensure compliance with regulatory standards.

Posted 4/15/2026full-timeRemote • 🇪🇸 SpainSeniorWebsite

About the role

Key responsibilities & impact

Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs

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
Computer literacy (MS Office/ Office 365)
Fluent in English
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

Benefits

Comp & perks

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
Health insurance
401(k) matching
Flexible work hours
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory guidanceregulatory submissionsdocument reviewregulatory complianceproject managementstrategic regulatory inputdrug development processregulatory milestonesscientific advice procedurespost-approval submissions

Soft Skills

leadershipcommunicationcoordinationteamworkcustomer engagement

Certifications

Bachelor's degree