Global Regulatory Submissions Manager

Proclinical Staffing; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading life sciences recruiter in the UK is seeking a Regulatory Operations Manager to drive global compliance and spearhead regulatory submissions. This mid-senior level role involves managing the compilation and quality of submission documents, interpreting regulatory standards, and ensuring compliance within various regulatory frameworks. Candidates require a BS degree and a robust background in regulatory operations, with outstanding skills in project management and electronic submission processes. Proclinical is acting as an Employment Agency for this vacancy.

Qualifications

• Solid understanding of regulatory submissions including electronic submissions.
• Expert in electronic submission requirements (FDA, EMA, ROW).
• Strong attention to detail and communication skills.

Responsibilities

• Manage document quality control and archiving throughout the product lifecycle.
• Facilitate submission timelines and ensure mutual understanding with project teams.
• Conduct proactive review and QC of all RIM records associated with submissions.

Skills

Regulatory submissions process

MS Word formatting

Project management concepts

Analytical skills

Interpersonal skills

Education

BS in a relevant field

Tools

Regulatory Information Management (RIM) System

EDMS

eCTD Publishing

Job description

A leading life sciences recruiter in the UK is seeking a Regulatory Operations Manager to drive global compliance and spearhead regulatory submissions. This mid-senior level role involves managing the compilation and quality of submission documents, interpreting regulatory standards, and ensuring compliance within various regulatory frameworks. Candidates require a BS degree and a robust background in regulatory operations, with outstanding skills in project management and electronic submission processes. Proclinical is acting as an Employment Agency for this vacancy.