Global Regulatory Affairs: Associate Director, Compliance

Scorpion Therapeutics; Cambridge (MA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus eligibility

Benefits package

Job summary

Scorpion Therapeutics is seeking an Associate Director of Global Regulatory Affairs, Compliance in Cambridge, MA. The role focuses on translating laws and guidance into regulatory strategies to support business objectives and compliance.

The position requires 8+ years in Regulatory Affairs, strong regulatory writing skills, and the ability to lead submissions and inspections. Onsite work is required at least 2 days per week with ~10% travel. Base pay ranges; equity/bonus may be offered.

Qualifications

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience in technical and regulatory writing.
• Ability to independently plan, prioritize, and meet deadlines.

Responsibilities

• Translate applicable laws, regulations, and guidance into regulatory strategies supporting compliance and business objectives.
• Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to regulatory submission documents (INDs, NDAs) and related correspondence.
• Review regulatory submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs for compliant operations.
• Provide regulatory expertise during regulatory and quality inspections.
• Maintain current knowledge of regulatory requirements including 21 CFR parts and ICH guidelines.

Skills

Regulatory writing

Regulatory strategy

Regulatory compliance

Cross-functional collaboration

Regulatory submissions

Documentation review

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Scorpion Therapeutics is seeking an Associate Director of Global Regulatory Affairs, Compliance in Cambridge, MA. The role focuses on translating laws and guidance into regulatory strategies to support business objectives and compliance.

The position requires 8+ years in Regulatory Affairs, strong regulatory writing skills, and the ability to lead submissions and inspections. Onsite work is required at least 2 days per week with ~10% travel. Base pay ranges; equity/bonus may be offered.