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RA Manager

Location: Singapore, Singapore Salary: competitive
Sector: Regulatory Affairs (RA) Type: Permanent

Manager, Regulatory Affairs, Singapore

Position Responsibilities:

  • 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.
  • Requirements
  • 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)

Award winner of:

International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017