Remote Regulatory Manager - Global Clinical Submissions

Precision Medicine Group; United Kingdom; Remote; GBP 70,000 - 110,000; Full time

Job summary

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. This role supports regulatory strategy, regulatory submissions, and interactions with agencies for clinical trials, orphan designations, and paediatric planning, including accelerated procedures.

The ideal candidate has 5–7 years in regulatory affairs, CRO/pharma experience, and strong knowledge of EU/US regulations, ICH GCP, and cross-functional collaboration.

Qualifications

• Bachelor's degree is required or equivalent experience
• 5 years regulatory experience for Manager level and 7 years for Senior Manager
• Broad knowledge of drug development processes and regulatory milestones (EU/US)
• Experience in CRO or pharmaceutical industry with leadership of clinical submissions
• Ability to interpret clinical/pre-clinical data for regulatory strategy and timelines
• Willingness to travel domestically and internationally
• Excellent interpersonal and team collaboration skills
• Strong English communication (verbal and written) and professional conduct

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review regulatory applications to Authorities including CTA/IND and amendments
• Develop and review documents for submissions to Regulators and Ethics Committees
• Represent Global Regulatory Affairs at project team meetings with internal and external stakeholders
• Lead regional or global project efforts and coordinate Regulatory Affairs Specialists
• Maintain project plans, trackers and regulatory intelligence tools
• Contribute to regulatory strategy and timelines for new studies
• Support training of staff and continuous process improvement

Skills

Regulatory strategy

Leadership

Submission management

Global regulatory

Communication

Project management

ICH GCP

Clinical submissions

Travel readiness

Education

Bachelor's degree

Job description

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. This role supports regulatory strategy, regulatory submissions, and interactions with agencies for clinical trials, orphan designations, and paediatric planning, including accelerated procedures.

The ideal candidate has 5–7 years in regulatory affairs, CRO/pharma experience, and strong knowledge of EU/US regulations, ICH GCP, and cross-functional collaboration.