Country Approval Specialist (Pharmaceutical, Remote/Nordics & Poland)

Job summary

This role involves managing and coordinating local regulatory submissions in the pharmaceutical sector, ensuring alignment with global strategies. The Country Approval Specialist will work closely with internal teams and may interact with investigators to facilitate submission-related activities.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Minimum of 2 years of experience in a related role.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions, including those for the Ministry of Health and Ethics Committees.
• Provide local regulatory strategy advice to internal stakeholders.
• Coordinate with internal departments to align site start-up activities with submission timelines.
• Maintain trial status information in tracking databases accurately and timely.
• Develop country-specific patient information and consent documents as needed.
• Assist with grant budgets and payment schedule negotiations with sites.

Skills

• Strong oral and written communication skills.
• Excellent interpersonal and negotiation skills.
• Attention to detail and quality documentation.
• Proficient computer skills and ability to learn new software.
• Basic knowledge of medical terminology and regulatory guidelines.

Education

• Bachelor's degree or equivalent.

Tools

• Familiarity with regulatory submission software and tracking databases.