Regulatory Manager / Senior Regulatory Manager

Precision Medicine Group; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading clinical research organization is seeking a Regulatory Manager based in the UK. This role involves providing regulatory strategy and guidance for clinical trials, ensuring timely, compliant regulatory submissions, and leading project teams. A Bachelor’s degree and over five years of regulatory experience are required. Strong communication skills in English and knowledge of drug development processes are essential.

Qualifications

• 5+ years of regulatory experience for Manager level, 7 years for Senior Manager.
• Experience in Clinical Research Organisation and leading clinical submissions.
• Knowledge of drug development and regulatory activities in major regions.

Responsibilities

• Provide regulatory guidance throughout clinical development.
• Compile and review applications such as CTA/IND and marketing applications.
• Lead or participate in project teams for regulatory submissions.

Skills

Regulatory strategy guidance

Document preparation

Regulatory submissions management

Interpersonal skills

Proficiency in English communication

Education

Bachelor’s degree in a scientific or healthcare field

Job description

Precision for Medicine (CRO) is recruiting a Regulatory Manager to join our team. Candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.

The Regulatory Manager (RM) provides regulatory strategy and guidance for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated procedures. The RM ensures timely, well-organized, and compliant regulatory submissions. Responsibilities include preparing documents for submission to authorities and ethics committees, maintaining current knowledge of regulations, and supporting the regulatory function of the organization.

Essential functions include:

• Providing regulatory guidance throughout clinical development
• Compiling and reviewing applications such as CTA/IND, annual reports, amendments, and marketing applications
• Developing and reviewing submission documents for compliance
• Representing Global Regulatory Affairs in project meetings
• Leading or participating in project teams
• Overseeing Regulatory Affairs Specialists to meet submission targets
• Maintaining project plans and regulatory intelligence tools
• Supporting development of Regulatory Affairs staff
• Contributing to regulatory strategy and timelines for new studies
• Participating in corporate quality initiatives
• Staying updated on laws, regulations, and guidelines
• Providing ICH GCP guidance and training
• Representing Regulatory Affairs in business development meetings

Qualifications:

• Bachelor’s degree or equivalent, preferably in a scientific or healthcare field
• At least 5 years of regulatory experience for Manager level, 7 years for Senior Manager

Preferred:

• Basic understanding of financial management

Other requirements:

• Experience working in a Clinical Research Organisation and leading clinical submissions
• Knowledge of drug development, regulatory milestones, and activities in major regions (EU, US)
• Ability to interpret clinical and pre-clinical data for regulatory strategy
• Understanding of clinical trial methodology
• Willingness to travel domestically and internationally
• Strong interpersonal and teamwork skills
• Professionalism, punctuality, and commitment
• Ability to manage multiple tasks efficiently
• Self-motivated and proactive in work planning
• Effective communication skills in English, both verbal and written