Senior Director, Regulatory Strategy

Scorpion Therapeutics; Washington (District of Columbia); On-site; USD 150,000 - 230,000; Full time

Job summary

Scorpion Therapeutics in Washington, DC, seeks a senior Regulatory Affairs leader to drive strategy for complex development programs from first-in-human to post-marketing. You will represent GRA on core project teams and align regulatory input with clinical and commercial objectives.

Leading global regulatory strategies, mentoring staff, and guiding cross-functional teams will be central to this role. You will influence policy, improve processes, and ensure timely regulatory submissions across

Qualifications

• Bachelor's degree required; typically 12+ years in pharma/biotech regulatory affairs.
• 5+ years supervisory/management experience.
• Experience leading regulatory strategy for development programs from FIH to post-marketing.

Responsibilities

• Lead development of regulatory strategy for development projects (F IH to post-marketing).
• Represent GRA on core/project teams; align with regional leaders for clinical programs and commercial strategy.
• Provide guidance on global regulatory strategies, tactics, procedures, and practices to cross-functional teams and senior management.
• Develop and manage project plans and timelines; assign/manage resources to meet goals on time.
• Influence regulatory environment via conferences, agency meetings, committees, and trade associations; stay current on regulations and policy.

Skills

Regulatory Leadership

Stakeholder Influence

Strategic Regulatory

Global Frameworks

Health Authority Interactions

People Development

Education

Bachelor's degree in Biology/Chemistry

Job description

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).