Regulatory Affairs Associate Director / Director

Singapore - Singapore

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 (Masters or PhD) in Pharmacy Biology or a related discipline.
Over 5 years of international regulatory affairs experience having led at least two successful FDA or EMA drug approvals from initiation to completion.
Skilled in electronic submission platforms (e.g. Veeva RIM)
Specialized in registering vaccines and biologics covering areas such as influenza COVID-19 and HPV.
Previous experience as a reviewer or regulator at FDA EMA or MHRA is advantageous.

Registration Number: R1331018

Triton AI Pte Ltd

EA License Number: 21C0661

Required Experience:

Director

Job DescriptionResponsibilities: 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 ...