Regulatory Affairs Officer

• Prepare, compile, and review US DMFs (Type II), EU ASMFs, and other region-specific dossiers.
• Manage lifecycle activities such as updates, deficiency responses, and annual reports.
• Collaborate with internal teams to gather technical documents for submissions.

• Compile CTD/eCTD dossiers for global regulatory submissions (USFDA, EDQM, WHO, TGA, etc.).
• Ensure adherence to current international regulatory guidelines and standards.
• Maintain accurate records, document control systems, and submission archives.

• Coordinate with QA, QC, R&D, and Production teams for necessary documentation and technical inputs.
• Support preparation and review of product specifications, stability data, and Certificates of Analysis (COAs).

• Provide assistance during regulatory audits and inspections by international authorities and clients.
• Address regulatory queries and observations in a timely manner.

• Monitor and interpret updates in global regulatory guidelines (USFDA, EMA, ICH, etc.).
• Provide inputs on regulatory strategies, product classification, and compliance requirements.

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• 3-7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, nutraceuticals, or herbal formulations.
• Strong understanding of DMF/ASMF preparation and submission processes.
• Familiarity with global regulatory frameworks (USFDA, EMA, TGA, WHO, etc.).
• Excellent documentation, communication, and organizational skills.
• High attention to detail with the ability to manage deadlines effectively.

Weekday AI