Director of Regulatory Affairs

We're partnering with a mid-sized biotech company based in the Boston area that's advancing a differentiated pipeline across clinical stages. Due to continued growth, they are looking to bring on a Director of Regulatory Affairs to lead strategy and execution for key programs.Key ResponsibilitiesLead global regulatory strategy for clinical-stage programsDrive major submissions (INDs, CTAs, NDAs/BLAs) and oversee lifecycle managementPartner cross-functionally with Clinical, CMC, Nonclinical, and Commercial teamsProvide strategic input to development plans, timelines, and risk mitigationRepresent Regulatory Affairs at program team and leadership meetingsManage external consultants/vendors and contribute to building internal capabilitiesRequired QualificationsBachelor's degree in life sciences, pharmacy, or related scientific field10-15+ years of Regulatory Affairs experience within biotech or pharmaceutical industryStrong expertise in U.S. FDA regulations and regulatory pathwaysProven experience supporting or leading IND submissions and clinical-stage developmentDemonstrated involvement in major regulatory filings (e.g., IND, NDA, BLA)Experience acting as a regulatory lead on cross-functional program teamsAbility to develop and execute regulatory strategy (not just support operations)Strong communication skills, with experience interfacing with internal stakeholdersAbility to work in a fast-paced, mid-sized environmentPreferred QualificationsAdvanced degree (MS, PhD, PharmD, or MBA)Experience leading global regulatory strategy (EMA, MHRA, ICH regions)Direct interaction with health authorities (FDA meetings, Scientific Advice)Experience in oncology, rare disease or CNSFamiliarity with expedited regulatory pathways (Fast Track, Breakthrough Therapy, Orphan Drug)Experience supporting business development, licensing and due diligence activitiesBackground in both small/mid-sized biotech and larger pharma environments

Created: 2026-05-09