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.

Interested? We are looking forward to get in touch with you.