Role Description:

This role is to coordinate and manage regulatory affairs so as to support Regulatory & Medical Affairs Manager and to ensure efficient functioning of DRA team within organization

Responsibilities:

• Keep abreast of the local and global regulatory environment and execute assigned regulatory activities.
• Preparation of documentations for regulatory submissions (including new product submissions, change in particulars, tender submissions) to authorities including HK Department of Health, Hospital Authority, or Macau MoH.
• Maintain centralized databases on regulatory activities and update accordingly; perform regular follow ups on assigned products and tasks according to business priorities.
• Ensure proper filing and records keepings for regulatory documentations.
• Supports ad-hoc tasks assigned by line manager or Country Head Sandoz Hong Kong.
• Work closely with various internal departments and distributors in maintenance of product supply continuity and ensuring regulatory compliance in Hong Kong and Macau.
• Assist in ensuring compliance to Corporate Standards, local and international regulatory requirements.
• Assist in handling ad-hoc projects and QA-related duties.

Qualifications:

• Degree holder in Pharmaceutical Studies or other science related discipline.
• Good command of English and Chinese.
• 1- 2 years’ relevant working experience.
• Hands-on regulatory affairs experiences in pharmaceutical industry will be an definite advantage.
• Good team player with strong communication skills.
• Self-motivated and fast learner.
• Good knowledge of MS Office and Excel.