Regulatory Manager – Senior Regulatory Manager

Precision For Medicine

Regulatory Manager at Precision for Medicine providing regulatory strategy and development guidance for clinical trials. Overseeing submissions and ensuring compliance with regulations in oncology and rare diseases.

Posted 4/15/2026full-timeRemote • 🇷🇴 RomaniaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

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
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of 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
Computer literacy (MS Office/ Office 365)
Fluent in English

Benefits

Comp & perks

Precision Medicine Group is an Equal Opportunity Employer
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law
Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory guidanceregulatory submissionsregulatory complianceproject managementregulatory strategyclinical developmentICH GCPregulatory intelligence

Soft Skills

leadershipcommunicationcollaborationstrategic thinking