Associate Director / Senior Regulatory Affairs

Innovative Biopharmaceutical Company | Northwestern Switzerland

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

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

Your Profile

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

Preferred Experience

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

What You Can Expect

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

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