Associate Clinical Trials Regulatory Manager, EMEA

IQVIA AG seeks an Associate Clinical Trials Regulatory Manager for EMEA to oversee regulatory submissions and provide strategic guidance for global clinical programs.

This position functions as a process management role rather than a people management position. The primary purpose is to deliver regulatory support and oversight for clinical trial submissions across various global programs, ensuring compliance and timely delivery.

Responsibilities

• Act as the Clinical Trial Regulatory Manager for complex projects.
• Offer strategic guidance and regulatory oversight to internal and external teams.
• Evaluate scientific and regulatory materials, perform gap analyses, and suggest improvements.
• Draft and review essential documents such as IMPDs and clinical trial justifications.
• Manage European centralized submissions and assist with global country filings.
• Ensure all project outputs meet deadlines, scope, and regulatory standards.
• Keep internal systems, databases, and tracking tools updated according to SOPs.
• Provide regulatory insights to support business development efforts.
• Conduct regulatory training sessions and presentations when needed.
• Guide junior staff and participate in knowledge-sharing activities within the department.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.
• Typically 3–5 years of experience in Regulatory Affairs within pharma, biotech, CRO, or clinical research sectors.
• Proven track record in supporting clinical trial submissions and handling regulatory documentation.
• Strong understanding of clinical trial regulations and submission procedures.