Associate Clinical Trials Regulatory Manager

EMEA

Homebased

Job Summary

The Associate Clinical Trials Regulatory Manager provides regulatory support and oversight for clinical trial submissions across global programs. This role is responsible for preparing and reviewing regulatory documentation, managing submissions, ensuring regulatory compliance, and supporting clients and internal stakeholders throughout the clinical trial lifecycle. This is not a people manager role, but a process management position.

Key Responsibilities

• Serve as the Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects and programs.

• Provide regulatory oversight and strategic guidance to internal and external stakeholders.

• Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations.

• Author and/or review key regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications.

• Coordinate and support European centralized submissions and global country submissions.

• Ensure project deliverables are completed on time, within scope, and in compliance with regulatory requirements.

• Maintain accurate records in internal systems, databases, and tracking tools in accordance with SOPs.

• Support business development activities by providing regulatory expertise.

• Deliver regulatory training and presentations as required.

• Mentor junior team members and contribute to departmental knowledge sharing initiatives.

Qualifications and Experience

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.

• Typically 3–5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or clinical research industry.

• Experience supporting clinical trial submissions and regulatory documentation.

• Strong scientific writing, document review, project management, and stakeholder engagement skills.

• Advanced knowledge of clinical trial regulations and regulatory submission processes.

Knowledge & Competencies

• Advanced knowledge of regulatory affairs and clinical trial submission requirements.

• Strong analytical and problem-solving skills.

• Excellent communication and collaboration abilities.

• Ability to work independently and manage multiple priorities in a fast-paced environment.