Global Country Regulatory Submissions Specialist

Remote Worker LTD.; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

Remote Worker LTD. is seeking a Country Approval Associate to coordinate local regulatory submissions and align them with global strategy.

You will liaise with MoH/EC and other national bodies, guiding internal teams on local regulatory matters and coordinating country-specific SIA services. The role supports site activation timelines and collaborates with cross-functional teams to ensure timely submissions and compliance with regional guidelines.

Qualifications

• Bachelor's degree or equivalent required.
• 2+ years of relevant regulatory/ submissions experience preferred.
• Equivalency of education, training, and experience may be considered.

Responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, other national/local applications) per global strategy.
• Provide local regulatory strategy guidance to internal clients.
• Coordinate country-specific SIA services and project-specific activities.
• Act as country level contact for submission-related activities.
• Ensure site start-up activities align with submission timelines and critical path.

Skills

Communication

Interpersonal skills

Attention to detail

Negotiation skills

English proficiency

Medical terminology

Teamwork

Organization

Regulatory knowledge

Computer skills

Education

Bachelor's degree

Job description

Remote Worker LTD. is seeking a Country Approval Associate to coordinate local regulatory submissions and align them with global strategy.

You will liaise with MoH/EC and other national bodies, guiding internal teams on local regulatory matters and coordinating country-specific SIA services. The role supports site activation timelines and collaborates with cross-functional teams to ensure timely submissions and compliance with regional guidelines.