Regulatory Affairs Specialist

About the Role

The Regulatory Affairs Product Specialist supports US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. Responsibilities include planning, authoring, compiling, and submitting statutory reports in eCTD format, as well as managing post-approval changes and regulatory strategies.

Responsibilities

• Plan, author, compile, and submit statutory reports in eCTD format for marketed products per FDA requirements.
• Review and assess CMC regulatory impact of post-approval changes proposed at manufacturing sites and provide regulatory strategy.
• Plan, author, compile, submit, and manage variations and supplements for marketed products within and outside the United States.
• Participate in cross-functional teams and provide health authority requirements for post-approval changes.
• Author and review updates to marketed product labeling.
• Maintain regulatory knowledge of current guidelines and regulations.
• Maintain current regulatory databases and produce reports as needed.
• Utilize and support electronic document management systems.
• Provide mentorship for entry-level regulatory associates.
• Maintain operational compliance with US and international regulatory agencies (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Author, organize, and prepare electronic (eCTD) regulatory filings, including peer review.
• Identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements.
• Manage multiple priorities and attend necessary trainings/seminars to stay updated on regulatory changes.
• Critically review documentation for regulatory submissions and provide input for revisions.

Requirements

• Bachelor’s Degree in a scientific discipline or equivalent work experience.
• Minimum of 3 years of Regulatory experience or related field.
• Cross-functional interaction experience, including coordinating activities and driving projects to completion.
• Project leadership experience preferred.
• Strong organizational skills, attention to detail, and ability to problem-solve.
• Excellent written and oral communication skills.
• Experience with change control software systems.
• Proficiency in Microsoft Office tools and Adobe Acrobat.

Working Conditions

• Standard office environment.
• Team-based work with close attention to detail required.
• May require sitting or standing for long periods (8+ hours per day).
• Position involves multiple deadlines; overtime, weekend, or holiday work may be required.

Schedule

Monday – Friday, 8:00 AM – 5:00 PM.