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Job Details

Location
Singapore
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-18078
Contact
Roselle Cuntapay
Posted
about 1 month ago
Another new entrant to the Singapore scene, this is an established Asian Pharmaceutical company who are looking to build out a team in Singapore to focus on the SEA market. They are currently looking for a Regulatory Affairs Director to oversee regulatory activities as they look to get their list of established products approved for the SEA markets.
 
They already have an office space, products approved for other locations, a director to work with and a strong commitment to expansion in the region. This will be one of their first hires here in SG so will be crucial in helping to form the culture and success of the office.
 
As the Regulatory Affairs Director you will lead all things RA, you will have market & business level influence and responsibility and is considered a key opinion leader and an expert resource within the SEA business.
 

The Regulatory Affairs Director will be responsible for:

  • Develops and provides registration strategies with its timeline, way to accelerate, anticipate potential risks with mitigation plan of assigned products/projects handling complicated issues, seeking guidance where appropriate.
  • Handling new product submissions and product lifecycle management, variations, through authority, and cross-functional engagement to ensure input from cross-functional team members and issues regional regulatory plans as appropriate.
  • Prepares and maintains local SOPs and policies relevant to Regulatory Affairs to comply with the company's policies and local regulation.
  • Provides regulatory input and support for marketing plans, product launches, and other cross-functional activities.

 
The Regulatory Affairs Director will be / have:

  • Experience within Regulatory Affairs and of product registration across the SEA region.
  • Degree qualified
  • Strong knowledge of regulations across the region.

 
If you feel you would be suitable then please apply now.



Reg No. R1871342
BeathChapman Pte Ltd
Licence no. 16S8112