EU Regulatory Lead / EU Regulatory Lead

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EU Regulatory Lead – 7111

Our client provides cross-functional consulting services aimed at empowering pharmaceutical, biotech, and medtech organizations. They support these companies in achieving sustainable success and maintaining industry standards while navigating the complex international regulatory landscape throughout the lifecycle of medicinal products, devices, IVDs, and combination products. Their services also include personalized, expert-led support in development, regulatory affairs, quality assurance, pharmacovigilance, medical and regulatory communications, market access, public affairs, healthcare compliance, project management, and establishing and scaling companies.

We are currently seeking a highly experienced EU Regulatory Lead to assist with the planning, preparation, and submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA). This role is an initial 6–12-month contract that offers the flexibility of remote work, based in Switzerland, with a commitment of 50% to 70% full-time equivalent (FTE).

Main Responsibilities:

• Provide strategic EU regulatory leadership and advice for the preparation and submission of the MAA to the EMA.
• Lead and guide the EU regulatory submission strategy, ensuring alignment with EMA requirements and timelines.
• Act as the primary regulatory representative for the client in interactions with EMA and other relevant European regulatory stakeholders.
• Professionally represent the company in regulatory meetings, discussions, and submission-related interactions.
• Offer regulatory input and oversight throughout the preparation of the MAA, including reviewing key regulatory documentation and submission components.
• Collaborate closely with the client, partner pharmaceutical companies, and internal/external stakeholders to align on regulatory strategies, responsibilities, timelines, and deliverables.
• Provide strategic advice on regulatory questions, potential risks, issues, and opportunities linked to the EU development and submission pathway.
• Facilitate discussions across cross-functional and cross-company teams, ensuring regulatory considerations are fully integrated into the overall submission strategy.
• Support the preparation for and participation in EMA interactions and regulatory meetings, including the development and review of briefing materials and responses.
• Track and communicate regulatory commitments, actions, and submission milestones to stakeholders.
• Identify potential regulatory risks and proactively devise strategies and mitigation plans.
• Serve as a trusted regulatory advisor, delivering clear and 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.
• Extensive experience in pharmaceutical regulatory affairs, particularly in EU regulatory strategy and MAA submissions.
• Demonstrated experience leading or providing 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 effectively interact with European regulatory authorities.
• Strong experience in managing multiple stakeholders, especially in complex partnerships or sponsor/vendor environments.
• Excellent stakeholder management, communication, negotiation, and influencing skills.
• Ability to provide strategic regulatory advice while addressing operational submission requirements.
• Experience working in cross-functional, international teams across different time zones.
• Excellent written and verbal communication skills in English.
• Ability to work independently in a 100% remote environment while actively engaging with global teams.
• Willingness and flexibility to attend occasional late-evening meetings to accommodate US-based stakeholders.

Interested in learning more about CTC and this exciting opportunity? Apply online using the form below. Please note that only applications matching the job profile will be considered.