Regulatory Manager / Senior Regulatory Manager

TN United Kingdom; United Kingdom; Remote; GBP 50,000 - 90,000; Full time

Job summary

An innovative clinical research organization is seeking a Regulatory Manager to lead regulatory strategy and submissions for clinical trials. This role involves providing expert guidance, ensuring compliance with regulations, and collaborating with internal and external stakeholders. The successful candidate will have a strong background in regulatory affairs, with at least five years of experience, and will be responsible for overseeing regulatory submissions and supporting the development of regulatory staff. This is a fantastic opportunity to contribute to impactful projects in a dynamic environment, with the flexibility of remote work.

Qualifications

• 5+ years of regulatory experience for Manager level, 7 years for Senior Manager.
• Experience in leading clinical submissions and knowledge of drug development process.

Responsibilities

• Provide regulatory guidance throughout the clinical development lifecycle.
• Compile and review applications to regulatory authorities, ensuring compliance.
• Represent Global Regulatory Affairs at project meetings with stakeholders.

Skills

Regulatory Strategy

Clinical Trials Guidance

Regulatory Submissions

Project Management

Interpersonal Skills

Education

Bachelor's Degree in Scientific or Healthcare Discipline

Tools

Regulatory Intelligence Tools

Job description

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Regulatory Manager / Senior Regulatory Manager, remote, United Kingdom

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Job Category:

Other

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EU work permit required:

Yes

Job Reference:

6881cee1b300

Job Views:

6

Posted:

05.05.2025

Expiry Date:

19.06.2025

Job Description:

Precision for Medicine (CRO) is recruiting a Regulatory Manager to join our team. Candidates can be based in the 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, organized, and quality regulatory submissions compliant with applicable regulations. The RM coordinates and prepares regulatory documents for submission to authorities and ethics committees. The RM maintains current knowledge of regulations, provides analysis to project teams, and supports the company's regulatory functions.

Essential functions include:

• Providing regulatory guidance throughout the clinical development lifecycle
• Compiling, coordinating, and reviewing applications to regulatory authorities, including CTA/IND, annual reports, amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications, along with strategic input
• Developing and reviewing documents for regulatory submissions to ensure compliance
• Representing Global Regulatory Affairs at project meetings with internal and external stakeholders
• Leading projects regionally or globally as needed
• Overseeing Regulatory Affairs Specialists to meet submission targets
• Maintaining project plans, trackers, and regulatory intelligence tools
• Supporting the development of regulatory staff
• Contributing to regulatory strategy and timeline development for new studies
• Participating in corporate quality initiatives
• Staying updated on laws, regulations, and guidelines governing drug development and approval
• Providing ICH GCP guidance and training
• Representing Regulatory Affairs in business development meetings

Qualifications:

• Bachelor's degree or equivalent in a scientific or healthcare discipline
• 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 for a Clinical Research Organisation and leading clinical submissions. Knowledge of drug development process, regulatory milestones, and activities for major regions (EU, US), including submissions, scientific advice, and post-approval activities. Ability to interpret clinical and preclinical results, understanding of clinical trial methodology, and knowledge of relevant regulations. Willingness to travel domestically and internationally. Strong interpersonal, communication, and project management skills. Ability to work independently and in teams, prioritize tasks, and continuously improve processes.