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gloor&lang AG

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<h2>Innovative Biopharmaceutical Company | Northwestern Switzerland</h2>
Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development and NDA Filing. 
Our client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development. 
As the lead program approaches a pivotal clinical readout and future registration activities, we are looking for a senior Regulatory Affairs professional with substantial NDA filing experience and a strong background in clinical development. 
A key objective of the role is to consolidate regulatory expertise internally: coordinating external regulatory partners, progressively taking ownership of critical activities, and ensuring strategic oversight across the development and submission program.

Your Responsibilities 
<ul>
<li>Develop and coordinate the global regulatory strategy for late-stage clinical development, pivotal milestones and future registration.</li>
<li>Drive NDA planning and filing readiness, including cross-functional submission strategy, timelines, responsibilities and review processes.</li>
<li>Coordinate external regulatory consultants and submission partners while progressively taking ownership of key Regulatory Affairs activities in-house.</li>
<li>Plan, prepare and lead interactions with regulatory agencies, including FDA, EMA and other relevant Health Authorities.</li>
<li>Ensure regulatory alignment across clinical, nonclinical and CMC development activities and translate development plans into clear regulatory pathways.</li>
<li>Provide senior regulatory input for IND, IMPD and CTA activities and ensure consistency with the future marketing application strategy.</li>
<li>Build and retain regulatory knowledge, documentation, processes and decision history within the organization.</li>
<li>Represent Regulatory Affairs in multidisciplinary development teams and collaborate closely with Clinical Development, CMC, Quality, Medical, Safety and external partners.</li>
<li>Identify regulatory gaps, risks and critical decision points and provide pragmatic recommendations to senior management.</li>
</ul>

Your Profile 
<ul>
<li>Degree in Pharmacy, Chemistry, Pharmaceutical Sciences or another Life Science discipline.</li>
<li>Approximately 10+ years of broad Regulatory Affairs experience within biotech or pharmaceutical development, ideally with senior-level responsibility.</li>
<li>Clearly demonstrable hands-on experience with at least one NDA filing and a strong understanding of filing readiness and submission execution.</li>
<li>Proven experience supporting clinical development programs through late-stage development and into a first marketing application.</li>
<li>Direct communication and interaction experience with regulatory agencies, particularly FDA and/or EMA.</li>
<li>Good CMC Regulatory Affairs understanding, including the ability to critically review and coordinate CTD Module 3 activities.</li>
<li>Experience working with external regulatory experts, consultants and service providers and the ability to bring regulatory knowledge and ownership in-house.</li>
<li>Experience with small molecule development is highly desirable; exposure to anti-infectives or antibiotics would be an additional advantage.</li>
<li>Excellent communication, influencing and stakeholder-management skills; fluent English.</li>
</ul>

Preferred Experience 
<ul>
<li>Experience supporting or leading a first marketing application from late-stage development through submission.</li>
<li>Strong familiarity with FDA NDA requirements and Health Authority meeting preparation, briefing packages and responses to questions.</li>
<li>Experience in a lean, innovative biotechnology environment with high individual accountability.</li>
<li>Ability to connect clinical development, CMC and overall regulatory strategy without operating in functional silos.</li>
<li>A pragmatic, hands-on mindset combined with the seniority to provide strategic regulatory leadership and challenge external partners when needed.</li>
</ul>

What You Can Expect 
<ul>
<li>A pivotal role at the transition from late-stage clinical development to future NDA filing.</li>
<li>The opportunity to shape and build the company's internal Regulatory Affairs capability and become the central point of regulatory coordination.</li>
<li>Close collaboration with senior scientific and development leaders, with broad visibility across the organization.</li>
<li>Substantial ownership and long-term impact in an agile biotechnology company addressing high unmet medical needs.</li>
</ul>

Associate Director / Senior Regulatory Affairs

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