Senior Director, Regulatory Clinical Strategy

Role: Lead regulatory project management and strategy across clinical development programs in biopharma, with emphasis on supporting drug registration and post-marketing activities. Responsibilities: develop and oversee global/regional regulatory strategies for complex projects from early clinical phases to post-approval; provide advanced regulatory guidance to cross-functional teams; influence regulatory policies through industry engagement; supervise and mentor staff, manage vendors, and support continuous process improvement. Qualifications: Bachelor's degree in life sciences with 10+ years, Master's with 8+ years, or Doctoral degree with 6+ years in Regulatory Affairs within the pharmaceutical industry; demonstrated expertise in regulatory pathways, FDA regulations, and global compliance; proven leadership, strategic thinking, and excellent communication skills. High-Value: oversight of regulatory strategy for drugs in development and post-market, including biological or pharmaceutical products; experience with IND, clinical phases, and regulatory submissions; leadership in cross-functional teams; knowledge of US and global regulations; management of regulatory interactions with agencies like the FDA. WorkSetup: unspecified, but likely hybrid or onsite based on seniority and scope.