Manager, Regulatory Affairs, Singapore
- Prepare regulatory applications and documents, within agreed timeframes.
- Identify all regulatory project for each functional area by project for global regulatory submissions.
- Carry out risk assessment and implement regulatory strategies for products in pre and post-approval stages.
- Help regulatory and project team to identify risks to meet regulatory submission goals, address any delays and escalates when necessary.
- Help with regulatory meetings and functional teams
- Assess and communicate regulatory intelligence and its potential impact.
- Maintain good working rapport and relationship with the regulatory agencies.
- Ensure good communication and understanding across different functional teams to provide accurate information and timelines.
- Prepare documents based required format.
- Bachelor's degree, preferably in a science related field.
- At least 5 years of relevant regulatory experience
- Able to work autonomously, multi task, works well under pressure
- Have excellent written and verbal communication skills
- Good team player and able to develop, implement and deliver.
- Good understanding of Regulatory Agency regulations, guidelines, and/or specifications (e.g., Asia, FDA, ICH, etc) preferred
- Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.To apply, please email CV to v.tan(a)realstaffing.com, or call +65 6871 4700 for further information.
EA License No: 16S8216
Registration No: R1873695
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
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International Recruitment Company of the Year by Recruitment International 2016
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