Senior Director, Regulatory Strategy
Scorpion Therapeutics
Key Duties & Responsibilities Lead development of regulatory strategy for multiple/complex development projects (first-in-human to post-marketing), including regulatory submission documents and Health Authority communications. Represent Global Regulatory Affairs (GRA) on core/project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy. Address complex regulatory issues; provide guidance to cross-functional teams; counsel senior management on global Regulatory Affairs strategies, tactics, procedures, and practices. Develop and manage project plans/timelines; assign/manage resources to prioritize work and meet goals on time. Influence regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations; stay current on regulations, policy, intelligence, and competitive issues. Lead continuous improvement of department processes/strategies. Lead GRA functional team(s); coach, develop, and provide performance feedback. People management may include financial and HR responsibilities for assigned staff. Required Knowledge & Skills Business-minded strategic leader; innovative solutions to regulatory problems. Excellent communication skills; ability to influence decisions; present and document regulatory strategy. Regulatory leadership in cross-functional, matrix environments. Deep expertise in regulatory affairs science and global/regional/local frameworks for human pharmaceutical development (research & development, preclinical/clinical, registration, maintenance). Advanced data/protocol/safety reporting/labeling interpretation across drug development phases. Expertise in proposing regulatory paths and clinical plans; lead productive Health Authority interactions. Ability to assess regulatory pathway adequacy and guide refinements based on regulatory outcomes. Ability to align with strategic vision/core values; improve internal regulatory policies/programs. Cultural sensitivity; embraces diversity; mentors and develops staff. Required Education & Experience Bachelor's degree in Biology, Chemistry, or related discipline. Typically 12 years' relevant pharmaceutical/biotech regulatory affairs experience and 5 years' supervisory/management experience (or equivalent). #J-18808-Ljbffr Scorpion Therapeutics
$232k - $348k
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