Global Regulatory Affairs Ops Leader - Compliance & Process

BioSpace; Boston (MA); Hybrid; USD 208,200 - 327,140; Full time

Benefits offered by this job

Competitive salary

Equitable pay practices

Hybrid work policy

Job summary

A leading biotech company in Boston seeks a Head of Global Regulatory Affairs Operations. This senior role focuses on overseeing global regulatory submissions and ensuring compliance across the PDT organization. The ideal candidate will have 7-10 years of experience in regulatory affairs within the pharmaceutical industry and excellent leadership skills. The position offers a hybrid work model and a competitive salary range of $208,200 - $327,140.

Qualifications

• 7-10 years of regulatory experience in the pharmaceutical/biotech industry.
• Experience in global drug development regulations and lifecycle management.
• Project management qualification is highly desirable.

Responsibilities

• Oversee global regulatory submissions for all PDT products.
• Guide compliance and efficiency initiatives across the organization.
• Manage relationships with 3rd party vendors supporting regulatory affairs.

Skills

Leadership skills

Regulatory compliance knowledge

Project management

Communication skills

Education

Bachelor's degree in a scientific field

Tools

Regulatory publishing tools

Information Management tools

Job description

A leading biotech company in Boston seeks a Head of Global Regulatory Affairs Operations. This senior role focuses on overseeing global regulatory submissions and ensuring compliance across the PDT organization. The ideal candidate will have 7-10 years of experience in regulatory affairs within the pharmaceutical industry and excellent leadership skills. The position offers a hybrid work model and a competitive salary range of $208,200 - $327,140.