Associate Director / Senior Regulatory Affairs

We are seeking an Associate Director / Senior Regulatory Affairs leader for an innovative, research‑driven biotechnology company based in north‑western Switzerland. The firm advances a portfolio of novel small‑molecule therapies that are currently in late‑stage clinical development and prepares for future registration. In this role you will shape and run the internal regulatory function. Core duties include designing the global regulatory strategy for late‑stage programs and pivotal milestones, steering NDA planning and filing readiness, and managing timelines, responsibilities and review processes. You will coordinate external regulatory consultants while progressively taking ownership of key activities in‑house, and you will lead interactions with agencies such as the FDA, EMA and other health authorities. Ensuring alignment across clinical, non‑clinical and CMC work streams, you will translate development plans into clear regulatory pathways, provide senior input for IND, IMPD and CTA submissions, and build a lasting knowledge base of regulatory documentation and decisions. As the regulatory voice in multidisciplinary teams, you will work closely with Clinical Development, CMC, Quality, Medical, Safety and external partners, spotting gaps, risks and critical decision points and offering pragmatic recommendations to senior management. The position requires a degree in Pharmacy, Chemistry, Pharmaceutical Sciences or another life‑science discipline, together with roughly ten years of broad regulatory affairs experience in biotech or pharmaceutical development, ideally at a senior level. You must have hands‑on experience with at least one NDA filing and a solid understanding of filing readiness and execution, as well as proven support of late‑stage programs through to a first marketing application. Direct communication with regulatory agencies, particularly the FDA and/or EMA, is essential, as is a good grasp of CMC regulatory affairs, especially CTD Module 3 review. Experience managing external regulatory experts and bringing that expertise in‑house, plus excellent communication, influencing and stakeholder‑management skills in fluent English, are also required. Desirable experience includes work on small‑molecule projects, especially anti‑infectives or antibiotics, and having led a first marketing application from late‑stage development through submission. Familiarity with FDA NDA requirements, meeting preparation and briefing packages is valued, as is a background in a lean, innovative biotech environment that demands high individual accountability. The ability to connect clinical development, CMC and overall regulatory strategy without siloing, combined with a pragmatic, hands‑on mindset and senior strategic leadership, will further strengthen your fit. The role offers a pivotal position at the transition from late‑stage clinical work to NDA filing, giving you the chance to build the company's internal regulatory capability and become the central coordination point. You will collaborate closely with senior scientific and development leaders, enjoy broad visibility across the organization, and have substantial ownership and long‑term impact in an agile biotech addressing high unmet medical needs. What the role asks for: - Degree in Pharmacy, Chemistry, Pharmaceutical Sciences or Life Science. - 10+ years regulatory affairs experience in biotech/pharma. - Hands‑on experience with at least one NDA filing. - Experience supporting late‑stage development to first marketing application. - Direct interaction experience with FDA and/or EMA. - Good CMC regulatory knowledge, CTD Module 3 review. - Experience managing external regulatory consultants and bringing knowledge in‑house. - Excellent communication and stakeholder‑management; fluent English. - Nice-to-have: Small‑molecule development experience. - Nice-to-have: Exposure to anti‑infectives or antibiotics. - Nice-to-have: Led first marketing application from late‑stage to submission. - Nice-to-have: Familiarity with FDA NDA requirements and meeting prep. - Nice-to-have: Experience in lean, innovative biotech environment. - Nice-to-have: Ability to integrate clinical, CMC and regulatory strategy. - Nice-to-have: Pragmatic hands‑on mindset with senior strategic leadership.