Remote Director, Global CMC Regulatory Strategy

Scorpion Therapeutics; United States; Remote; USD 190,000 - 285,000; Full time

Job summary

Scorpion Therapeutics seeks a Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma. The role reports to the Executive Director and operates remotely in the U.S. with quarterly visits to San Francisco.

You will develop CMC strategies, manage global submissions (ROW), coordinate regulator queries, and ensure compliance with global regulations while leveraging AI tools to increase efficiency.

Qualifications

• 7+ years in pharmaceutical/regulatory CMC functions.
• Bachelor's degree in life sciences or related field.
• Excellent communication and project management skills.
• Proficiency with Veeva and document management systems.
• Demonstrated ability to leverage AI tools for efficiency.

Responsibilities

• Develop CMC regulatory strategies for global submissions.
• Manage creation and submission of regulatory documentation (ROW marketing applications).
• Coordinate responses to health authority questions.
• Support interactions with regulators.
• Ensure compliance with global regulations.

Skills

Excellent communication

Project management

Education

Bachelor's degree in life sciences or related field

Tools

Veeva

AI tools for regulatory efficiency

Job description

Scorpion Therapeutics seeks a Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma. The role reports to the Executive Director and operates remotely in the U.S. with quarterly visits to San Francisco.

You will develop CMC strategies, manage global submissions (ROW), coordinate regulator queries, and ensure compliance with global regulations while leveraging AI tools to increase efficiency.