Strategic Regulatory Lead for Clinical Submissions

Precision Medicine Group; Greater London; On-site; GBP 85,000 - 125,000; Full time

Job summary

Precision for Medicine, part of Precision Medicine Group, is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. The role provides regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and orphan designations, ensuring timely, high-quality submissions.

You will coordinate regulatory documents for submission to authorities and ethics committees, lead project teams, and mentor regulatory staff while staying current

Qualifications

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

Responsibilities

• Provide regulatory guidance throughout the clinical development lifecycle.
• Coordinate and review applications to Regulatory Authorities including CTA/IND submissions and amendments.
• Develop/review documents for regulatory submissions to Authorities/Committees.
• Represent Global Regulatory Affairs at project team meetings.
• Lead region/global projects; oversee Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans and regulatory trackers; contribute to regulatory intelligence.
• Mentor Regulatory Affairs staff and contribute to training.
• Input into regulatory strategy and timelines for new study opportunities.
• Maintain knowledge of laws and guidelines governing drug development.
• Provide input in business development meetings.

Skills

Regulatory strategy

Regulatory submissions

Communication

Cross-functional collaboration

Project leadership

Education

Bachelor's degree

Job description

Precision for Medicine, part of Precision Medicine Group, is recruiting a Regulatory Manager / Senior Regulatory Manager to join our growing global team. The role provides regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and orphan designations, ensuring timely, high-quality submissions.

You will coordinate regulatory documents for submission to authorities and ethics committees, lead project teams, and mentor regulatory staff while staying current