Job Description

Regulatory Associate

Overview:

The Regulatory Associate will support the preparation, review, and submission of regulatory documentation to ensure compliance with global health authority requirements. This role works closely with cross-functional teams—including Quality, Manufacturing, R&D, and Project Management—to support product approvals, amendments, and ongoing regulatory maintenance throughout the product lifecycle.

Key Responsibilities:

• Prepare, compile, and format regulatory submissions (e.g., INDs, NDAs, ANDAs, BLAs, CTAs, annual reports, variations, supplements) in accordance with FDA, EMA, and other global regulatory requirements.
• Support regulatory strategy by providing input, conducting research on regulatory guidelines, and assisting in gap assessments.
• Maintain regulatory documentation systems, ensuring timely and accurate updates in compliance databases and tracking tools.
• Review technical documents for accuracy, clarity, and consistency prior to regulatory submission.
• Collaborate with cross-functional departments to gather data and ensure regulatory-compliant documentation related to manufacturing, testing, validation, and product change controls.
• Monitor and interpret regulatory changes, guidance, and industry standards; communicate relevant updates to internal stakeholders.
• Support regulatory inspections and audits by providing documentation and responding to regulatory requests.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Pharmacy, or related field.
• 1–3 years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industry.
• Strong understanding of FDA, ICH, and global regulatory guidelines.
• Excellent technical writing, organizational, and communication skills.
• Ability to manage multiple deadlines and work cross-functionally in a fast-paced environment.
• Experience with eCTD publishing tools and regulatory information systems is a plus.

Preferred Skills:

• Prior experience in a GMP manufacturing environment.
• Familiarity with CMC documentation and regulatory requirements for product lifecycle management.
• Strong attention to detail and critical thinking skills.

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