Remote Regulatory Manager – Clinical Submissions & Strategy

Precision Medicine Group

United Kingdom

Remote

GBP 70,000 - 110,000

Full time

5 days ago

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Job summary

Precision for Medicine, Remote, United Kingdom, seeks a Regulatory Manager / Senior Regulatory Manager to guide regulatory strategy for clinical trials, orphan designations, paediatric planning and accelerated procedures. You will coordinate regulatory submissions, liaise with authorities, and lead regulatory teams to ensure timely, compliant documentation.

The role requires 5+ years for Manager and 7+ years for Senior Manager in regulatory affairs, with CRO or pharmaceutical experience, and

Qualifications

Bachelor's degree or equivalent in a scientific/healthcare discipline.
5 years regulatory experience for Manager, 7 years for Senior Manager.
Experience in CRO or pharmaceutical industry regulatory affairs and leading clinical submissions.
Knowledge of regulatory activities for major regions (EU, US).

Responsibilities

Provide regulatory strategy and development guidance for clinical trials, regulatory submissions, and agency meetings.
Coordinate and prepare regulatory documents for submissions to Regulatory Authorities and Ethics Committees.
Lead regional or global regulatory projects and oversee Regulatory Affairs Specialists.
Maintain project plans and regulatory intelligence tools; contribute to regulatory strategy and timelines.