EU Regulatory Lead (7111)

Strategic EU Regulatory Leadership Opportunity

Join a specialized industry expert dedicated to helping companies source top talent and providing reliable HR and consulting services. Our client offers cross-functional consulting support to pharma, biotech, and medtech organizations, ensuring sustainable success and adherence to industry standards while navigating dynamic international regulatory landscapes. Their expertise spans the lifecycle of medicinal products, devices, IVDs, and combination products, including development, regulatory affairs, quality assurance, pharmacovigilance, medical and regulatory communications, market access, public affairs, healthcare compliance, and project management.

We are seeking a highly experienced professional to provide strategic EU regulatory leadership for the planning, preparation, and submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). This is a 6–12-month contract role, performed 100% remotely from Switzerland, requiring 50% to 70% full-time equivalent effort.

Key Responsibilities

• Provide strategic EU regulatory leadership and advice for the preparation and submission of the MAA to the EMA.
• Lead and provide strategic guidance on the EU regulatory submission strategy, ensuring alignment with applicable EMA requirements and timelines.
• Act as the primary regulatory representative for the client in interactions with the EMA and other relevant European regulatory stakeholders.
• Represent the company professionally and effectively in regulatory meetings, discussions, and submission-related interactions.
• Provide regulatory input and oversight throughout the preparation of the MAA, including review of key regulatory documentation and submission components.
• Work closely with the client, partner pharmaceutical company, and internal/external stakeholders to ensure alignment on regulatory strategy, responsibilities, timelines, and deliverables.
• Provide strategic advice on regulatory questions, potential risks, issues, and opportunities associated with the EU development and submission pathway.
• Coordinate and facilitate discussions across cross-functional and cross-company teams, ensuring regulatory considerations are appropriately incorporated into the overall submission strategy.
• Support preparation for and participation in EMA interactions and regulatory meetings, including development and review of briefing materials and responses.
• Ensure that regulatory commitments, actions, and submission milestones are appropriately tracked and communicated to stakeholders.
• Identify potential regulatory risks and proactively develop appropriate strategies and mitigation plans.
• Serve as a trusted regulatory advisor to the client and provide clear, pragmatic recommendations to senior stakeholders.
• Maintain effective communication with stakeholders across different geographies and time zones, including the US and Europe.

Qualifications and Experience

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or a related scientific discipline.
• Significant experience in pharmaceutical regulatory affairs, with substantial experience in EU regulatory strategy and MAA submissions.
• Demonstrated experience leading or providing strategic regulatory oversight for EU/EMA Marketing Authorisation Applications.
• Strong understanding of EMA regulatory procedures, requirements, and expectations for innovative pharmaceutical products.
• Experience in the Cardiovascular therapeutic area is highly desirable.
• Proven ability to act as a senior regulatory representative and interact effectively with European regulatory authorities.
• Strong experience managing multiple stakeholders across organizations, particularly in complex partnerships or sponsor/vendor environments.
• Excellent stakeholder management, communication, negotiation, and influencing skills.
• Ability to provide strategic regulatory advice while also understanding and addressing operational submission requirements.
• Strong experience working in cross-functional, international teams and across different time zones.
• Excellent written and verbal communication skills in English.
• Ability to work independently in a 100% remote environment while maintaining strong engagement with global teams.
• Willingness and flexibility to attend occasional late-evening meetings to accommodate US-based stakeholders.