Director/Senior Director Regulatory Affairs

Director / Senior Director, Regulatory AffairsWe are partnering with an innovative and growing biotechnology/pharmaceutical organization seeking a Director or Senior Director of Regulatory Affairs to join their team. This individual will play a key role in shaping and executing global regulatory strategy across development programs.This is a highly visible position working cross-functionally with clinical, CMC, and executive leadership, offering the opportunity to make a meaningful impact on advancing therapies to patients.Key ResponsibilitiesLead the development and execution of global regulatory strategies for assigned programsServe as the regulatory lead on cross-functional project teamsProvide strategic input across all stages of development (early through late-stage)Oversee preparation and submission of regulatory documents (e.g., INDs, CTAs, NDAs, BLAs, MAAs)Act as primary point of contact with global health authorities (e.g., FDA, EMA)Guide regulatory intelligence activities and ensure alignment with evolving regulationsSupport interactions, meetings, and communications with regulatory agenciesMentor and support junior regulatory team members as appropriateQualificationsBachelor's degree required; advanced degree (MS, PhD, PharmD) preferred~10–15+ years of regulatory affairs experience within biotech/pharmaExperience supporting regulatory strategy across multiple stages of developmentFamiliarity with global regulatory requirements and submissionsStrong cross-functional collaboration and communication skillsProven ability to operate in a fast-paced, evolving environmentPreferred ExperienceExperience in one or more therapeutic areas (flexible depending on background)Prior experience with both US and ex-US regulatory activitiesBackground in small molecule and/or biologics developmentExperience in a growing or mid-sized biotech environmentWhy JoinOpportunity to influence regulatory strategy at a program and organizational levelCollaborative, high-impact environment with strong leadership visibilityCompetitive compensation, bonus, and equity packageJ-18808-Ljbffr