Associate Director, Global Regulatory Affairs 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

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 for effective, compliant operations.
• 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:

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Demonstrated ability to interpret and apply laws, regulations, and guidance.
• Required experience in technical and regulatory writing.
• Proven ability to independently plan, prioritize, and accomplish goals using sound judgment.
• Detail-oriented; able to manage multiple priorities and deadlines.
• Flexible/adaptable in a fast-paced environment.
• Strong interpersonal skills and collaboration across functions.
• Strong professional judgment with external experts and health authorities.
• Excellent written and verbal communication skills.

Skills/Attributes:

• Strong organizational, project management, and problem-solving skills.
• Excellent oral/written/presentation skills; proactive, self-starter; works independently and in teams.

Benefits/Pay:

• Base pay range: $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.

Work location/travel:

• Cambridge, MA or San Francisco, CA; onsite at least 2 days/week; ~10% travel.