Regulatory Affairs Associate Director

Job Description

Responsibilities:

• Manage the entire process of getting new drugs approved in the US and EU, from initial research all the way through post-market changes.
• Develop and evaluate submission documents covering key administrative, summary, and clinical data, maintaining strict adherence to ICH and local regulations.
• Communicate directly with regulatory agencies like the FDA, EMA, and MHRA to handle questions, inspections, and label discussions.
• Help develop and carry out registration plans for new markets in regions like Southeast Asia (ASEAN) and the Middle East/North Africa (MENA).
• Work closely with different teams (like manufacturing and clinical research) to make sure all submitted information is scientifically sound.

Requirements:

• Advanced degree (Master's or PhD) in Pharmacy, Biology, or a related discipline.
• Over 5 years of international regulatory affairs experien...