Associate Director of Regulatory Operation

Major Responsibilities：

• To ensure adequate systems are in place to support the regulatory documentation, archiving, tracking and recording.
• To ensure adequate processes and procedures are developed and implemented in the regulatory COE to ensure compliance and quality.
• To provide strateagic and specific support and advice to the company on any regulation and/or policy changes to ensure company become aware and prepared and therefore to prevent or minimize any negative impact to company products or business.
• Actively participate and involve in the process of the development of new regulations and policies of SFDA and MOH to ensure company’s point of view have been clearly expressed and fairly considered.
• Establish and implement adequate Quality Control/Quality Assurance in the Regulatory Affairs operation to ensure quality of the regulatory submissions and compliance.
• To ensure adequate procedures and guidance for Due Diligence activities.

Requirement：

• A minimum of bachelor degree, preferable higher, (pharmacy, medical or related background) plus minimum 10 years regulatory affairs working experience.
• Excellent communication skills. Proven ability to communicate (written/oral) in English.
• Ability to present clearly and effectively to a variety of audiences, internally and externally.
• Good influence skills and ability.
• Good negotiation skills with internal and external costumers.
• Good leadership and teamwork skills.
• Ability to work with government officials and industry organizations