Executive Director, Regulatory Strategy, Cell & Gene Therapy

Scorpion Therapeutics; Washington (District of Columbia); On-site; USD 230,000 - 320,000; Full time

Job summary

Scorpion Therapeutics in Washington, DC seeks an Executive Director, Regulatory Strategy to oversee global regulatory strategies for the T1D portfolio and commercialization efforts. You will lead a team of regulatory professionals and shape cross-functional strategy across development, clinical, and commercial teams.

You will counsel senior management on strategies, coordinate submissions with health authorities, and drive process improvements to maintain efficient, compliant programs across

Qualifications

• Lead regulatory strategy for multiple T1D programs through FIH to post-marketing.
• Align global/regional strategy with corporate objectives and health authority negotiations.
• Coordinate input with global program leads and regional teams across development.
• Review, author, and ensure quality of regulatory submissions and Health Authority communications.
• Counsel senior management on regulatory tactics, procedures and practices.
• Create and assess project plans, assign staff, and support career growth.
• Influence the regulatory environment through conferences and trade associations.
• Sponsor continuous improvement of department processes and resource planning.

Responsibilities

• Lead regulatory strategy development for multiple T1D projects from FIH through post-marketing.
• Ensure global regulatory strategy aligns with business objectives and authorities.
• Coordinate unified regulatory input with program leads and regional reps.
• Review and author regulatory submissions and Health Authority communications.
• Advise senior management on strategy, tactics, and practices.
• Develop project plans, allocate staff, and manage timelines.
• Drive regulatory thought leadership by attending industry/regulator meetings.

Skills

Regulatory affairs expertise

Global regulatory strategy

Health authority interactions

Data analysis & interpretation

Leadership / matrix leadership

Project planning

Education

Bachelor's degree in Biology/ Chemistry

Job description

General Summary:

• The Executive Director, Regulatory Strategy will oversee development and implementation of global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals and shapes cohesive regulatory strategy across programs.

Key Duties And Responsibilities:

• Lead regulatory strategy development for multiple T1D projects from FIH through post-marketing application stages.
• Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
• Coordinate unified regulatory input with global program leads and regional representatives across development, clinical, and commercial teams.
• Review, author, and ensure quality of regulatory submission documents and Health Authority communications.
• Counsel senior management on Regulatory Affairs strategy/tactics, procedures, and practices.
• Create/assess project plans and timelines; assign/manage staff; prioritize work and meet key goals; support staff career growth.
• Influence the regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations.
• Sponsor continuous improvement of department processes/strategies; provide resource planning recommendations.

Knowledge And Skills:

• Expertise in regulatory affairs science and global/regional/local regulatory frameworks for pharmaceutical development.
• Advanced knowledge of R&D, preclinical/clinical requirements, drug registration, and maintenance.
• Strong skills in analyzing/interpreting data, protocols, safety reporting, and labeling.
• Advanced ability to create and assess regulatory path/clinical plan proposals and lead health authority interactions.
• Ability to navigate ambiguity; strategic thinking; excellent written/verbal communication; strong matrix leadership.

Education And Experience:

• Bachelor’s degree in Biology, Chemistry, or related field.
• Typically 15 years of relevant pharmaceutical/biotech regulatory affairs experience and 7 years supervisory/management experience (or equivalent).