European Regulatory Affairs Lead – EMA & Submissions

Skilled – Recruitment Solutions GmbH; Basel; On-site; CHF 180,000 - 280,000; Full time

Job summary

Skilled – Recruitment Solutions GmbH is seeking an accomplished Regulatory Affairs leader to guide European regulatory strategy for a pharmaceutical/biotech portfolio. The role interfaces with EMA and national authorities, designs pathways, and leads submissions throughout lifecycle.

You will mentor cross-functional teams, shape clinical development plans, and ensure robust labeling and compliance while driving global regulatory roadmaps and keeping stakeholders aligned across regions.

Qualifications

• Advanced degree in Life Sciences or related field.
• 8+ years in Regulatory Affairs in pharma/biotech.
• Deep knowledge of European, ICH and international regs.
• Direct EMA and national authority interaction track record.
• Understanding of clinical drug development and lifecycle.
• Strong project management and stakeholder communication.

Responsibilities

• Design and implement European regulatory pathways aligned with global development roadmaps.
• Serve as regional liaison to EMA and coordinate with national authorities.
• Prepare briefing documents for Scientific Advice and regulatory negotiations.
• Oversee European filing processes including clinical trials and marketing applications.
• Ensure labeling complies with central product data sheets.
• Provide regulatory guidance to governance committees and project teams.
• Lead global regulatory roadmaps and regional execution planning.
• Monitor regulatory changes and assess impact on portfolios.

Skills

English fluency

Education

Master's degree in Life Sciences

Job description

Skilled – Recruitment Solutions GmbH is seeking an accomplished Regulatory Affairs leader to guide European regulatory strategy for a pharmaceutical/biotech portfolio. The role interfaces with EMA and national authorities, designs pathways, and leads submissions throughout lifecycle.

You will mentor cross-functional teams, shape clinical development plans, and ensure robust labeling and compliance while driving global regulatory roadmaps and keeping stakeholders aligned across regions.