Associate Director / Senior Regulatory Affairs

h3Innovative Biopharmaceutical Company | Northwestern Switzerland /h3 h3Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development and NDA Filing. /h3 pOur client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development. /p pAs 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. /p pA 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. /p h3Your Responsibilities /h3 ul liDevelop and coordinate the global regulatory strategy for late-stage clinical development, pivotal milestones and future registration. /li liDrive NDA planning and filing readiness, including cross-functional submission strategy, timelines, responsibilities and review processes. /li liCoordinate external regulatory consultants and submission partners while progressively taking ownership of key Regulatory Affairs activities in-house. /li liPlan, prepare and lead interactions with regulatory agencies, including FDA, EMA and other relevant Health Authorities. /li liEnsure regulatory alignment across clinical, nonclinical and CMC development activities and translate development plans into clear regulatory pathways. /li liProvide senior regulatory input for IND, IMPD and CTA activities and ensure consistency with the future marketing application strategy. /li liBuild and retain regulatory knowledge, documentation, processes and decision history within the organization. /li liRepresent Regulatory Affairs in multidisciplinary development teams and collaborate closely with Clinical Development, CMC, Quality, Medical, Safety and external partners. /li liIdentify regulatory gaps, risks and critical decision points and provide pragmatic recommendations to senior management. /li /ul h3Your Profile /h3 ul liDegree in Pharmacy, Chemistry, Pharmaceutical Sciences or another Life Science discipline. /li liApproximately 10+ years of broad Regulatory Affairs experience within biotech or pharmaceutical development, ideally with senior-level responsibility. /li liClearly demonstrable hands-on experience with at least one NDA filing and a strong understanding of filing readiness and submission execution. /li liProven experience supporting clinical development programs through late-stage development and into a first marketing application. /li liDirect communication and interaction experience with regulatory agencies, particularly FDA and/or EMA. /li liGood CMC Regulatory Affairs understanding, including the ability to critically review and coordinate CTD Module 3 activities. /li liExperience working with external regulatory experts, consultants and service providers and the ability to bring regulatory knowledge and ownership in-house. /li liExperience with small molecule development is highly desirable; exposure to anti-infectives or antibiotics would be an additional advantage. /li liExcellent communication, influencing and stakeholder-management skills; fluent English. /li /ul h3Preferred Experience /h3 ul liExperience supporting or leading a first marketing application from late-stage development through submission. /li liStrong familiarity with FDA NDA requirements and Health Authority meeting preparation, briefing packages and responses to questions. /li liExperience in a lean, innovative biotechnology environment with high individual accountability. /li liAbility to connect clinical development, CMC and overall regulatory strategy without operating in functional silos. /li liA pragmatic, hands-on mindset combined with the seniority to provide strategic regulatory leadership and challenge external partners when needed. /li /ul h3What You Can Expect /h3 ul liA pivotal role at the transition from late-stage clinical development to future NDA filing. /li liThe opportunity to shape and build the company's internal Regulatory Affairs capability and become the central point of regulatory coordination. /li liClose collaboration with senior scientific and development leaders, with broad visibility across the organization. /li liSubstantial ownership and long-term impact in an agile biotechnology company addressing high unmet medical needs. /li /ul #J-18808-Ljbffr