Senior Regulatory Affairs CMC (ADC/Biologics)

This full-time remote position involves leading global regulatory CMC strategy for antibody-drug conjugate and biologics programs. The consultant will manage the preparation, submission, and lifecycle of Marketing Authorisation Applications and Biologics License Applications. Day-to-day tasks include overseeing Module 3 content, ensuring scientific consistency, and coordinating responses to agency queries. The role requires driving cross-functional collaboration within a matrix environment to align technical and program teams. You must maintain expertise in ICH, FDA, and EMA requirements to support successful product registration. The position demands strong leadership in anticipating regulatory risks and developing mitigation plans. It also involves leading interactions with health authorities such as the FDA and EMA on CMC topics. The employer seeks a candidate with a Master’s degree or equivalent qualification. No specific language requirements are stated in the provided text. The working arrangement is fully remote, allowing for flexibility in location. This role suits a senior professional experienced in strategic regulatory leadership for complex biologic products.