Global Country Submissions Specialist

ThermoFisher Scientific; Denmark; Remote; DKK 650,000 - 850,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Country Approval Specialist to support local regulatory submissions and coordinate with MoH and EC in line with global strategy. You will liaise with internal teams, investigators, and sites to ensure timely, compliant submissions and country-specific patient information materials where needed.

The role requires a Bachelor’s degree or equivalent and 2+ years of related experience, strong communication, and a solid understanding of regional regulatory

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 2+ years of relevant experience or more.

Responsibilities

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC) in line with global strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates project-specific local SIA services and submissions.
• May interact with investigators for submission-related activities.
• Acts as country-level contact for submission-related activities.
• Ensures site start-up activities align with submission timelines and critical path.
• Maintains trial status information on PPD tracking databases.
• Keeps local country study files and filing up-to-date.
• Stays current with PPD SOPs and regulatory guidelines.

Skills

Communication skills

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Regulatory knowledge

Teamwork/independence

Planning skills

Regulatory guidelines knowledge

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is seeking a Country Approval Specialist to support local regulatory submissions and coordinate with MoH and EC in line with global strategy. You will liaise with internal teams, investigators, and sites to ensure timely, compliant submissions and country-specific patient information materials where needed.

The role requires a Bachelor’s degree or equivalent and 2+ years of related experience, strong communication, and a solid understanding of regional regulatory