Associate Director Regulatory Affairs (m/f/d)

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

• Strategic Direction: Design and implement European regulatory pathways that seamlessly align with worldwide clinical development roadmaps.
• Health Authority Interface: Act as the primary regional liaison for the European Medicines Agency (EMA) and coordinate communications with various national competent authorities across Europe.
• Agency Meetings: Direct the compilation, preparation, and execution of briefing documents for Scientific Advice procedures and other critical regulatory negotiations.
• Submission Management: Oversee complex European filing processes, including clinical trial applications, pediatric plans, orphan drug designations, initial marketing authorizations, and continuous lifecycle variations.
• Labeling & Compliance: Ensure regional labeling requirements are met and remain strictly consistent with central core product data sheets.
• Cross-Functional Leadership: Provide authoritative regulatory guidance to internal governance committees, global project groups, and due diligence activities for business development.
• Global Alignment: Drive international regulatory roadmaps, orchestrate worldwide submission planning, and guide regional sub-teams and affiliates to ensure successful local execution.
• Regulatory Intelligence: Monitor the evolving regulatory landscape to evaluate the strategic impact of new guidelines on the portfolio.

Your Profile

• Education: Advanced university degree (Master's level or equivalent) in Life Sciences or a related scientific discipline.
• Industry Experience: Extensive senior-level background (8+ years) in Regulatory Affairs within the pharmaceutical or biotechnology sector.
• Regulatory Mastery: In-depth knowledge of European, ICH, and international regulatory frameworks.
• Agency Track Record: Proven history of direct interaction and successful collaboration with the EMA and European national competent authorities.
• Development Knowledge: Profound understanding of all phases of clinical drug development and post-approval lifecycle management.
• Leadership & Communication: Exceptional project management capabilities paired with strong stakeholder communication skills.
• Languages: Full professional fluency in English, both written and spoken.