Associate Director, Global Regulatory Affairs Compliance

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.