Regulatory Strategy Director
$196.8k - $295.2kScorpion Therapeutics
General Summary The Regulatory Strategy Director will develop and implement global/regional regulatory strategies for assigned projects within the Vertex portfolio. Key Duties And Responsibilities Lead development of regulatory strategy for assigned projects/regions (from first-in-human through post-marketing application) per Global Regulatory Strategy Documents. Represent GRA on core development and project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy. Address complex issues with innovative regulatory solutions; align cross-functional communications with GRA teams and leadership. Anticipate global regulatory changes and develop proactive strategy. Shape regulatory strategy for submission documents and Health Authority communications. Counsel GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures, and practices. Ensure strategies align with business objectives and comply with current regulations and guidance. Manage project plans/timelines to ensure prioritization and on-time goals. Contribute to continuous improvement of department processes/strategies. Provide regulatory leadership for GRA functional teams/projects with moderate resource requirements or complexity. Knowledge And Skills Experienced in Regulatory Affairs strategy in assigned geographic region; direct stakeholder interactions. Advanced regulatory affairs science knowledge, including global/regional/local legislation and guidance for human pharmaceutical development. Proficient in R&D, preclinical/clinical requirements for drug development, registration, and maintenance. Ability to analyze/interpret data, protocols, safety reporting, labeling, and phase-related activities. Advanced skill in proposing regulatory paths/clinical plans; guide teams based on regulatory outcomes; lead productive health authority interactions. Coaches and mentors others. Collaborative; builds consensus; clear, compelling communication and influence. Education And Experience Bachelor’s degree in Biology, Chemistry, or related discipline. Typically 10 years relevant pharmaceutical/biotech regulatory affairs experience (or equivalent combination). Pay Range $196,800 - $295,200 #J-18808-Ljbffr Scorpion Therapeutics
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