Global Regulatory Manager: Clinical Trials Strategy

Precision For Medicine; Greater London; Vor Ort; GBP 70.000 - 110.000; Vollzeit

Zusammenfassung

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. You will provide regulatory strategy and development guidance for clinical trials, agency meetings, and orphan/pediatric programs, ensuring timely, compliant submissions.

You will coordinate regulatory documents for regulatory authorities and ethics committees, lead regional or global submissions, supervise specialists, and contribute to ongoing regulatory intelligence and

Qualifikationen

• Bachelor's degree or equivalent in scientific/healthcare discipline.
• 5 years regulatory experience for Manager level; 7 years for Senior Manager.
• Experience in CRO or pharmaceutical industry and leading clinical submissions.
• Knowledge of EU/US regulatory processes and submissions.
• Willingness to travel domestically and internationally.

Aufgaben

• Provide regulatory guidance across clinical development lifecycle.
• Coordinate submissions to Regulatory Authorities including CTA/IND, amendments and meetings.
• Develop documents for submissions to authorities/ethics committees.
• Represent Global Regulatory Affairs in project teams with internal and external stakeholders.
• Lead regional or global regulatory projects and coordinate teams.
• Maintain project plans and regulatory intelligence tools.
• Support regulatory strategy and timelines for new study opportunities.

Kenntnisse

Regulatory strategy

Regulatory submissions

Regulatory affairs

Project leadership

International travel

Team collaboration

Quality compliance

Ausbildung

Bachelor's degree in science/healthcare

Jobbeschreibung

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. You will provide regulatory strategy and development guidance for clinical trials, agency meetings, and orphan/pediatric programs, ensuring timely, compliant submissions.

You will coordinate regulatory documents for regulatory authorities and ethics committees, lead regional or global submissions, supervise specialists, and contribute to ongoing regulatory intelligence and