Associate Director, Global Regulatory Affairs Compliance

Scorpion Therapeutics; San Francisco (CA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

Scorpion Therapeutics is seeking an Associate Director, Global Regulatory Affairs, Compliance to translate laws into regulatory strategies and support compliance and business objectives.

You will author and contribute to regulatory submissions (INDs/NDAs) and related correspondence, review submissions for accuracy, and maintain current knowledge of 21 CFR parts and ICH guidelines. This role demands strong writing, cross-functional collaboration, and proactive leadership.

Qualifications

• Bachelor's degree in scientific/related discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Demonstrated ability to interpret/apply laws, regulations, and regulatory guidance.
• Required: technical and regulatory writing experience.

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, health authority meeting materials) and related correspondence.
• Review regulatory submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.
• Maintain current knowledge of pharmaceutical development concepts and regulatory requirements (including 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, 314) and relevant ICH guidelines.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Attention to detail

Independent planning

Education

Bachelor's degree in scientific/related discipline

Advanced degree preferred

Tools

Regulatory writing tools

Job description

Associate Director, Global Regulatory Affairs, Compliance

Responsibilities:

• Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance and business objectives.
• Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to compliance of regulatory submission documents (INDs, NDAs, health authority meeting materials) and related correspondence.
• Review regulatory submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.
• Maintain current knowledge of pharmaceutical development concepts and regulatory requirements (including 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, 314) and relevant ICH guidelines.

Qualifications (Required/Preferred):

• Bachelor's degree in scientific/related discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Demonstrated ability to interpret/apply laws, regulations, and regulatory guidance.
• Required: technical and regulatory writing experience.

Skills/Attributes:

• Independently plan/prioritize and use sound judgment.
• Detail-oriented, highly organized; manage multiple priorities/deadlines.
• Strong interpersonal skills; collaborate across functions.
• Excellent written/verbal communication; strong oral/presentation skills.
• Flexible, proactive self-starter; able to work independently and in teams.

Comp/Benefits (if applicable):

Base pay range expected $190,000-$210,000 annually; total compensation includes equity, bonus, and benefits.