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Regulatory Affairs Associate Director
Job summary
A leading pharmaceutical consultancy in Singapore is seeking an experienced regulatory affairs professional to manage the approval processes for new drugs and vaccines. The ideal candidate will have an advanced degree in Pharmacy or Biology and over 5 years of international regulatory affairs experience, with a proven track record of handling FDA and EMA approvals. This role involves developing submission documents and communication with regulatory agencies to ensure compliance and successful product registrations.
Qualifications
- Over 5 years of international regulatory affairs experience.
- Led at least two successful FDA or EMA drug approvals.
- Specialized in registering vaccines and biologics.
Responsibilities
- Manage the entire process of getting new drugs approved.
- Develop and evaluate submission documents.
- Communicate directly with regulatory agencies.
- Help develop registration plans for new markets.
- Work closely with different teams to ensure accuracy.
Skills
Education
Tools
- 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.
- Advanced degree (Master’s 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
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.