Global Regulatory Submissions Specialist

ThermoFisher Scientific; United States; Remote; USD 75,000 - 110,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage local regulatory submissions and coordinate with internal teams to align with global strategy.

The role requires a Bachelor's degree or equivalent and 2+ years of regulatory experience, with strong communication, organizational, and regulatory knowledge. Office-based position with standard work hours; high attention to detail and teamwork are essential.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 2+ years of experience in a similar regulatory role.
• Equivalency may be considered with education, training and/or directly related experience.

Responsibilities

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC) in alignment with global submission strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates cross-functional site start-up activities and submission timelines.
• May interact with investigators for submission-related activities.
• Maintains trial status information and country study files per SOPs.

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage local regulatory submissions and coordinate with internal teams to align with global strategy.

The role requires a Bachelor's degree or equivalent and 2+ years of regulatory experience, with strong communication, organizational, and regulatory knowledge. Office-based position with standard work hours; high attention to detail and teamwork are essential.