Associate Director Regulatory Affairs (m/f/d)
Company: Skilled Recruitment Solutions GmbH Agency
- Location: Basel, Switzerland
- Seniority: Senior
- Employment type: Full-time
- Posted: 11 days ago
- Offer language: English
Job description
Your Key Responsibilities
- 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.
