Associate Director, Global Regulatory Affairs Compliance

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.

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Worksite address

boston, MA, 02298, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.