Associate Director – Regulatory Affairs Europe

🔥 14 hours ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Develop and execute European regulatory strategy for assigned development programs • Lead regulatory planning and execution for the centralized European Marketing Authorisation Application (MAA), including pre-submission activities, dossier strategy, submission readiness, health authority review and lifecycle management • Coordinate cross-functional development and review of regulatory submissions with Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, Commercial and other functions • Lead preparation of responses to EMA assessment questions, including Day 120 and Day 180 review milestones • Develop regulatory strategies, briefing packages and meeting preparation for interactions with EMA, MHRA, Swissmedic and other European authorities • Lead or support European paediatric regulatory activities, including Paediatric Investigation Plans (PIPs) and PDCO interactions • Provide regulatory leadership for clinical trial activities conducted through CTIS, including initial applications, substantial modifications and ongoing maintenance • Identify and communicate emerging regulatory risks, opportunities and requirements, translating them into recommendations and mitigation plans • Contribute to European labeling, product information, Risk Management Plans and other registration or post-authorization activities • Represent Regulatory Affairs on development teams and governance forums and contribute to broader global regulatory strategy • Build partnerships across functions and external stakeholders, facilitate timely decisions and resolve complex regulatory issues • Maintain regulatory quality, compliance and integrity of decision-making

🎯 Requirements

• Degree in life sciences, pharmacy, medicine or a related scientific discipline • Advanced degree preferred • Significant progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry • Strong expertise in European drug development and registration • Demonstrated experience with a centralized European Marketing Authorisation Application (MAA), including substantial involvement in strategy, dossier preparation, submission and health authority review • Practical experience preparing and coordinating responses to EMA assessment questions and interacting with European regulatory authorities • Experience with PIP/PDCO activities and EU Clinical Trials Regulation / CTIS requirements • Strong knowledge of EU pharmaceutical legislation, EMA procedures, ICH guidelines, GCP and applicable European regulatory requirements • Experience with MHRA and/or Swissmedic highly desirable • Ability to interpret complex scientific and regulatory information and translate it into clear, actionable recommendations • Strong communication, influencing, negotiation and project leadership skills • Ability to operate effectively across functions and organizational levels • Comfortable working independently and taking ownership of outcomes • Collaborative and solution-oriented, with intellectual curiosity, sound judgment and openness to alternative perspectives • Ability to balance speed and pragmatism with scientific rigor, regulatory compliance and high-quality execution

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Domestic and international travel opportunities (approximately 10–20%)