Associate Director, Global Regulatory Affairs Compliance

Olema Oncology; Boston (MA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

Job summary

Scorpion Therapeutics in Boston seeks an Associate Director, Global Regulatory Affairs, Compliance to translate laws into practical regulatory strategies supporting development and business objectives. You will ensure high-quality, timely execution of regulatory activities and milestones.

Responsibilities include authoring and reviewing regulatory submissions (INDs, NDAs), maintaining current knowledge of 21 CFR Parts and ICH guidelines, and guiding regulatory inspections with cross-functional

Qualifications

• Bachelor’s degree in a scientific or related discipline required.
• 8+ years of Regulatory Affairs experience in pharmaceutical/biotechnology.
• Technical and regulatory writing experience required.

Responsibilities

• Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies.
• 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 for 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 and ICH guidelines.

Skills

Independently plan/prioritize

Strong interpersonal skills

Excellent written/verbal communication

Flexible, proactive

Education

Bachelor's degree in a scientific or related discipline

Advanced degree preferred

Job description

Associate Director, Global Regulatory Affairs, Compliance

Responsibilities

• Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development 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 compliant operations.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.
• Maintain current knowledge of pharmaceutical development concepts and regulatory requirements, including relevant 21 CFR Parts and ICH guidelines.

Qualifications / Preferred Experience

• Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharmaceutical/biotechnology.
• Demonstrated ability to interpret and apply applicable laws, regulations, and guidance.
• Required: technical and regulatory writing experience.

Skills/Attributes

• Independently plan/prioritize using sound judgment; detail-oriented; manage multiple priorities/deadlines.
• Strong interpersonal skills; collaborate cross-functionally; sound judgment with external stakeholders.
• Excellent written/verbal communication; strong organizational/project management/problem-solving.
• Flexible, proactive self-starter; works independently and in teams.

Compensation/Benefits (as stated): Base pay range expected $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.