Director Regulatory Affairs EU/International

vor 6 Stunden

Zug, Zug, Schweiz Actalent Vollzeit

On behalf of our client, a biotech company focused on rare diseases, we are looking for a Director Regulatory Affairs EU/International.

This role will work collaboratively with the Regulatory and R&D teams on projects for late-stage development programs. The selected candidate will be tasked with drafting, reviewing and finalizing content and modules for INDs and IMPDs, and preparing NDA and MAA related content for EMA and other international regulatory bodies as needed.

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit

Responsibilities


• Develops the EU and international regulatory strategy for assigned projects aligned with the global regulatory strategy


• Implements the EU and international regulatory strategy through effective project and time management with the aim to deliver rapid approvals with optimal labelling identified by the business, markets, and patients


• Leads cross-functional teams and the preparation for EU and international health authority interactions (such as briefing books for scientific advice and/or health authority meetings) and actively participates in health authority meetings


• Supports the planning and preparation of the EU and international regulatory dossiers according to the company's submission plans


• Leads the preparation of regulatory submissions in accordance with local guidelines, manages the timely finalization of these submissions


• Contributes to response preparation to EU and international health authority questions including label negotiations, ensures complete and consistent response packages in line with the global development strategy to secure approvals


• Serves as primary point of contact for assigned health authorities


• Ensures effective teamwork across Regulatory Affairs and functional areas, enabling rapid and effective submissions, approvals, and product maintenance activities


• Provides regulatory support for clinical trial applications and overall development program

Requirements


• MSc degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable


• 10+ years' experience in drug development, 8+ years in regulatory


• Experience as direct contact person with major health authorities, e.g. European Medicines Agency


• Experience in developing materials, attending, and supporting team preparation for major health authority interactions


• Detailed knowledge of regulatory drug development including product approval/launch


• Ability to think strategically and critically evaluate risks to regulatory activities in a business-critical and high-profile development program


• A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs across the responsibilities of the specific role


• Experience in therapies for rare diseases and small molecules


• Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components


• Excellent verbal and written communication and presentation skills (English). Fluency in writing regulatory documents such as IMPDs, INDs, NDAs, MAAs


• Strong team player and ability to work across functions (matrix regulatory team)


• Comfortable in a small company environment that is fast paced, challenging and where all leaders must take a hands-on approach to get results


• Ability to multi-task and manage workload independently


• Excited and driven by science and the vision to improve disease management and patient care

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