Director, Regulatory Affairs – Biologics

MCRA, an IQVIA business; United States; On-site; USD 100,000 - 150,000; Full time

Job summary

MCRA, an IQVIA business, is looking for a Director of Regulatory Affairs to support regulatory strategy and submissions. The role involves managing regulatory submissions for FDA products and mentoring junior team members.

Qualified candidates should have at least five years of experience in Regulatory Affairs and a Bachelor’s degree in a scientific discipline. Strong analytical and communication skills are essential for this position. MCRA values diversity and offers equal opportunities.

Qualifications

• Minimum five years of experience in Regulatory Affairs with FDA products.
• Experience in project management or managerial roles.
• Understanding of FDA regulations and clinical development.

Responsibilities

• Manage regulatory submissions for client companies.
• Develop regulatory strategy and communicate with regulatory bodies.
• Lead business development functions to secure new clients.

Skills

Regulatory strategy development

Project management

Communication skills

Attention to detail

Analytical skills

Education

Bachelor’s degree in scientific discipline

MS or PhD preferred

Tools

MS Office

Excel

PowerPoint

Job description

MCRA, an IQVIA business, is looking for a Director of Regulatory Affairs to support regulatory strategy and submissions. The role involves managing regulatory submissions for FDA products and mentoring junior team members.

Qualified candidates should have at least five years of experience in Regulatory Affairs and a Bachelor’s degree in a scientific discipline. Strong analytical and communication skills are essential for this position. MCRA values diversity and offers equal opportunities.